{ "FullStudy":{ "Rank":217923, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01515072", "OrgStudyIdInfo":{ "OrgStudyId":"0120110125" }, "Organization":{ "OrgFullName":"Rutgers, The State University of New Jersey", "OrgClass":"OTHER" }, "BriefTitle":"Remote Ischemic Preconditioning in Neurological Death Organ Donors", "OfficialTitle":"Remote Ischemic Preconditioning in Neurological Death Organ Donors", "Acronym":"RIPNOD" }, "StatusModule":{ "StatusVerifiedDate":"November 2018", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"July 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"July 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"April 2015", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"October 28, 2011", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 23, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"April 28, 2016", "ResultsFirstSubmitQCDate":"April 6, 2017", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"June 20, 2017", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"November 28, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"December 19, 2018", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Baburao Koneru, MD, MPH", "ResponsiblePartyInvestigatorTitle":"Professor, New Jersey Medical School", "ResponsiblePartyInvestigatorAffiliation":"Rutgers, The State University of New Jersey" }, "LeadSponsor":{ "LeadSponsorName":"Rutgers, The State University of New Jersey", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Health Resources and Services Administration (HRSA)", "CollaboratorClass":"FED" },{ "CollaboratorName":"The University of Texas Health Science Center at San Antonio", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to determine whether application of lower limb remote ischemic preconditioning (RIPC) after determination of brain death improves donor stability, organ quality, organ yield, and early post transplant clinical outcomes.\n\nNeurological death donors will be stratified into standard and extended criteria donors (SCD/ECD) and randomized in a 1:1 fashion to RIPC or No intervention. The primary outcome is the number of organs recovered per donor. Secondary outcomes include donor hemodynamic state, donor organ-specific function parameters, pulsatile perfusion parameters, number of organs transplanted per donor, recipient hospital free survival and delayed graft function of kidneys. The sample size is powered to detect a difference of 0.44 organs recovered.", "DetailedDescription":"Study Design and Participants The RIPNOD trial was conducted from July 2011 to July 2014 as a prospective randomized trial in two OPOs (in New Jersey and in Texas) in the U.S. The funding organization, institutional review boards and the physician committees of the two organ procurement organizations (OPOs) approved the study. Exemptions for consent from potential recipients and for a data and safety monitoring board were granted. Consent for research was obtained from the donor's next of kin by OPO staff unless a 'first-person' consent existed. The study population consisted of neurological death organ donors. Eligible donors were age > 6 years, in whom death declaration was either imminent or completed, and organ recovery was not expected within 6 hours of enrollment. Donors with severe trauma to lower extremity or on sulfonylurea agents were excluded (Trial Protocol in Supplement).\n\nProcedures Randomization (1:1) to No RIPC or RIPC groups in standard and extended criteria donors (SCD and ECD) strata occurred based on a computer-generated random table of numbers. In Texas, field coordinators performed the randomization through a website and administered the intervention. In New Jersey, research staff performed all trial activities and randomized using opaque, sealed envelopes. Organ recovery teams were informed of the study and sometimes knew of the group assignment. The recipient care teams and recipients were not aware of the group assignment.\n\nThe intervention consisted of four cycles of inflation of a tourniquet around mid-thigh to 250 mm Hg for 5 minutes followed by 5 minutes of deflation. The initial intervention occurred in the right thigh as early as possible after declaration of death. The second intervention occurred in the left thigh 24 hours after the initial intervention, or immediately before recovery, if this was earlier. Videoconferences between the two sites helped standardize the intervention before the trial commenced. All decisions regarding donor management, organ recovery, machine perfusion of kidneys, transplantation of organs and care after transplantation were independent of the research teams.\n\nOutcomes and Data Collection The primary outcome was the total number of organs recovered per donor. Secondary outcomes were number of organs transplanted per donor, and changes from baseline to terminal (before aortic cross clamp) in vasopressor support, serum lactate, creatinine clearance, left ventricular ejection fraction, serum troponins, partial pressure of arterial oxygen: fraction inspired oxygen (P:F) ratio, dynamic and static lung compliance, and perfusate flow and resistance in machine perfused kidneys, delayed graft function (DGF) in transplanted kidneys and six-month hospital free survival in all recipients. A score quantified vasopressor support.14 All laboratory tests were performed at donor hospitals. Cockcroft-Gault equation was used to calculate creatinine clearance.15 Donor hospital cardiologists estimated the ventricular ejection fraction in transthoracic echocardiograms. OPO policies dictated machine perfusion of kidneys; perfusion, occurred at a central location in each OPO. Delayed graft function was defined as dialysis in the first week after transplant. Six month hospital-free survival was defined as the number of days recipients survived following the initial discharge after the transplant. All donor data were obtained prospectively from OPO records. Data after transplantation were obtained from the Scientific Registry of Transplant Recipients (SRTR). The SRTR data system includes data on all donors, waitlist candidates, and transplant recipients in the United States, submitted by members of the Organ Procurement and Transplantation Network (OPTN). The Health Resources and Services Administration (HRSA), U.S. Department of Health and Human Services provides oversight to the activities of the OPTN and SRTR contractors.\n\nSample Size A sample size of 150 donors in each arm was estimated to provide 80% power to detect a difference of 0.44 of an organ recovered and 0.48 of an organ transplanted per donor. The difference criterion was chosen based on published results achieved with hormonal resuscitation in organ donors. 6 Pooled standard deviations (organs recovered: 1.35; organs transplanted: 1.5) from data of two OPOs were used.\n\nStatistical Analyses Intention to treat principle was used in all analyses. Discrete descriptive data are reported as counts and percent and continuous data as means (sd) or medians (interquartile range). Continuous variables were compared using either t, or equivalent non-parametric tests. Categorical variables were compared using chi square tests. Multivariate modeling with backward elimination - linear ones to model RIPC on recovery and transplantation of all (0-8) and abdominal organs (0-5) per donor, and logistic ones to model recovery/transplantation of > 1 thoracic organ per donor and DGF - was performed. Because only seven fewer thoracic organs were transplanted than recovered the model for organs transplanted was used to analyze both outcomes. Donor characteristics of age, sex, race, cause of death, BMI, comorbidities (hypertension, diabetes, alcohol use, and hepatitis C), treatments (insulin, diuretics and steroids) and laboratory parameters (serum creatinine and P:F ratio) and OPO site were predictor variables in organ yield models. Donor age or stratum, cold ischemia, number of human leukocyte antigen mismatches and recipients' characteristics of age, sex, race, BMI, diabetes, hypertension, etiology of renal failure, panel reactive antibody and OPO site were predictor variables in models of DGF. For linear regression models, adjusted R2 was computed and residuals were assessed for normality; the C statistic was used to assess goodness of the fit for logistic regression. Statistical significance was set at p<0.05.\n\nPost Hoc Analyses Rates of acute rejection of kidney during the first six months were compared between the two groups using chi square tests. Kaplan-Meier estimates and log rank tests were used to compare unadjusted outcomes of graft and patient survival at 6, 12 and 24 months. In heart, lung and liver recipients, retransplantation or death was defined as graft loss. In all other organs graft loss was death-censored. Cox proportional hazards models were used to estimate the effect of RIPC on the adjusted hazard ratio for six-month graft loss after controlling for OPO site, donor age or stratum and sex, cold ischemia time, number of antigen mismatches, organ transplanted, and recipient age, sex, race, BMI, diabetes and hypertension." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Organ Transplantation" ] }, "KeywordList":{ "Keyword":[ "Remote Ischemic Preconditioning", "Brain death organ donors", "Delayed graft function", "Donor management", "Pulsatile perfusion" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"321", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"No Remote Ischemic Preconditioning", "ArmGroupType":"No Intervention", "ArmGroupDescription":"The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization." },{ "ArmGroupLabel":"Remote Ischemic Preconditioning", "ArmGroupType":"Experimental", "ArmGroupDescription":"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: RIPC (Remote Ischemic Preconditioning)" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Other", "InterventionName":"RIPC (Remote Ischemic Preconditioning)", "InterventionDescription":"Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Remote Ischemic Preconditioning" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Number of Organs Recovered Per Donor", "PrimaryOutcomeDescription":"Number of organs recovered per organ donor", "PrimaryOutcomeTimeFrame":"At time of organ recovery, up to 1 day" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Number of Organs Transplanted Per Donor", "SecondaryOutcomeDescription":"Number of organs transplanted from each organ donor", "SecondaryOutcomeTimeFrame":"Within 24 hours of organ recovery" },{ "SecondaryOutcomeMeasure":"Change in Vasopressor Score", "SecondaryOutcomeDescription":"Changes in the following: Vasopressor usage, serum Lactate, Creatinine clearance, arterial oxygen pressure:fraction of inspired oxygen (P:F) ratios, Lung Compliance, Cardiac biomarkers, ejection fraction (EF) from 2-dimensional Echocardiogram.\n\nHere we will present data for the change in vasopressor use evaluated using a vasopressor score.\n\nA numerical score calculated for number and dose of Vasopressors in use. The score is calculated using the following formula (from Zuppa AF et. al.CRIT CARE MED 2004 Vol. 32 p 2318-2322):\n\nVasopressor Score= (dopamine dose[y=ug/kg/min x 1]) + (dobutamine dose [ug/kg/min] x 1) + (epinephrine dose [ug/kg/min] x100) + (norepinephrine dose [ug/kg/min] x 100) + (phenylephrine dose [ug/kg/min] x 100).\n\nThe range for our study was 0-4900 with higher doses indicating higher vasopressor use in the donor.", "SecondaryOutcomeTimeFrame":"Vasopressor score was determined before aortic cross clamp minus the value prior to the first intervention, an average of 19 hours" },{ "SecondaryOutcomeMeasure":"Change in Serum Lactate", "SecondaryOutcomeDescription":"Change in serum lactate levels (mg/dL) from before intervention to the final value", "SecondaryOutcomeTimeFrame":"Subjects will be followed from admission to explantation, an average of 4.5 days" },{ "SecondaryOutcomeMeasure":"Change in Creatinine Clearance", "SecondaryOutcomeDescription":"Change in creatinine clearance (mL/min by Cockcroft-Gault method) from before intervention to terminal value", "SecondaryOutcomeTimeFrame":"Subjects will be followed from admission to explantation, an average of 4.5 days" },{ "SecondaryOutcomeMeasure":"Change in P:F Ratio", "SecondaryOutcomeDescription":"Change in ratio of arterial oxygen pressure:fraction inspired oxygen ratio from before intervention to terminal value", "SecondaryOutcomeTimeFrame":"Subjects will be followed from admission to explantation, an average of 4.5 days" },{ "SecondaryOutcomeMeasure":"Change in Dynamic Compliance", "SecondaryOutcomeDescription":"Change in dynamic compliance of the lung from before intervention to terminal value\n\nCdyn = Dynamic compliance; Vt = tidal volume; PIP = Peak inspiratory pressure (the maximum pressure during inspiration); PEEP = Positive End Expiratory Pressure:\n\nCdyn= Vt/PIP - PEEP", "SecondaryOutcomeTimeFrame":"Subjects will be followed from admission to explantation, an average of 4.5 days" },{ "SecondaryOutcomeMeasure":"Change in Troponins", "SecondaryOutcomeDescription":"Change in serum troponin I (ng/mL) from before intervention to terminal value", "SecondaryOutcomeTimeFrame":"Subjects will be followed from admission to explantation, an average of 4.5 days" },{ "SecondaryOutcomeMeasure":"Pulsatile Perfusion Flow", "SecondaryOutcomeDescription":"Perfusate flow (mL/min) in machine perfused kidneys.", "SecondaryOutcomeTimeFrame":"Up to 24 hours of machine perfusion" },{ "SecondaryOutcomeMeasure":"Six Month Hospital Free Survival of All Organ Recipients", "SecondaryOutcomeDescription":"Six month hospital-free survival was defined as the number of days recipients survived following the initial discharge after the transplant.", "SecondaryOutcomeTimeFrame":"6 months post-transplant" },{ "SecondaryOutcomeMeasure":"Delayed Graft Function (DGF) of Kidney Recipients.", "SecondaryOutcomeDescription":"DGF is defined as the need for dialysis within the first week post transplantation.", "SecondaryOutcomeTimeFrame":"7 days post-transplant" },{ "SecondaryOutcomeMeasure":"Pulsatile Perfusion Parameters", "SecondaryOutcomeDescription":"Perfusate resistance (mm Hg/mL/min) in machine perfused kidneys.", "SecondaryOutcomeTimeFrame":"Up to 24 hours of machine perfusion" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nNeurological death donors in whom brain death determination is imminent\nFirst person consent or next of kin consent for research\nDonors >=6 years of age\nOrgan recovery not expected within 6 hours of consent.\nBoth sexes and ethnicities.\n\nExclusion Criteria:\n\nDonation after cardiac death donors (DCD)\nLive organ donors\nNo first person consent and next of kin decline research consent\nDonor Age < 6 years\nLower extremity trauma or recent amputation\nTissue only donors", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"6 Years", "StdAgeList":{ "StdAge":[ "Child", "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Baburao Koneru, MD", "OverallOfficialAffiliation":"University of Medicine and Dentistry New Jersey-Newark", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"William K Washburn, MD", "OverallOfficialAffiliation":"University of Texas Health Sciences at San Antonio", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Rutgers, The State University of New Jersey", "LocationCity":"Newark", "LocationState":"New Jersey", "LocationZip":"07101", "LocationCountry":"United States" },{ "LocationFacility":"University of Texas Health Science Center at San Antonio", "LocationCity":"San Antonio", "LocationState":"Texas", "LocationZip":"78229", "LocationCountry":"United States" } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"No" } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowRecruitmentDetails":"The RIPNOD trial was conducted from July 2011 to July 2014 in two organ procurement organizations (OPO) in the U.S. Consent for research was obtained from donors next of kin by the OPO staff unless a 'first person' consent existed.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"No RIPC", "FlowGroupDescription":"The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"RIPC", "FlowGroupDescription":"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.\n\nRIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"166" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"155" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"There were 566 total organs transplanted and 248 kidneys transplanted in the No RIPC group.", "FlowAchievementNumSubjects":"166" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementComment":"There were 513 total organs transplanted and 235 kidneys transplanted in the RIPC group", "FlowAchievementNumSubjects":"155" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"All donors enrolled in both groups were included in the in-between group comparisons of baseline characteristics", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"No RIPC", "BaselineGroupDescription":"The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"RIPC", "BaselineGroupDescription":"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.\n\nRIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"166" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"155" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"321" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Median", "BaselineMeasureDispersionType":"Inter-Quartile Range", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"44", "BaselineMeasurementLowerLimit":"29", "BaselineMeasurementUpperLimit":"54" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"42", "BaselineMeasurementLowerLimit":"29", "BaselineMeasurementUpperLimit":"51" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"43", "BaselineMeasurementLowerLimit":"29", "BaselineMeasurementUpperLimit":"52" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Age, Customized", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"11-25", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"24" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"34" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"58" } ] } } ] } },{ "BaselineClassTitle":"26-35", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"39" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"27" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"66" } ] } } ] } },{ "BaselineClassTitle":"36-45", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"26" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"34" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"60" } ] } } ] } },{ "BaselineClassTitle":"46-75", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"77" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"60" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"137" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"59" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"62" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"121" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"107" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"93" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"200" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race/Ethnicity, Customized", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"White", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"97" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"74" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"171" } ] } } ] } },{ "BaselineClassTitle":"African-American", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"35" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"42" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"77" } ] } } ] } },{ "BaselineClassTitle":"Hispanic", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"30" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"38" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"68" } ] } } ] } },{ "BaselineClassTitle":"Other", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"5" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"United States", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"166" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"155" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"321" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Body Mass Index (BMI)", "BaselineMeasureDescription":"2 Categories < 30.0\n\n=/> 30.0", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"BMI < 30.0", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"126" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"104" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"230" } ] } } ] } },{ "BaselineClassTitle":"BMI =/> 30.0", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"40" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"51" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"91" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Hepatitis C Antibody", "BaselineMeasureDescription":"Serological test for Hepatitis C antibody:\n\nYes or No", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Yes", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"23" } ] } } ] } },{ "BaselineClassTitle":"No", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"159" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"139" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"298" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Co-Morbidities", "BaselineMeasureDescription":"Hypertension: Yes or No", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Hypertension: Yes", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"58" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"48" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"106" } ] } } ] } },{ "BaselineClassTitle":"Hypertension: No", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"108" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"107" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"215" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Central Line Use", "BaselineMeasureDescription":"Donors who had Central line in place: Yes or No", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Yes", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"121" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"116" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"237" } ] } } ] } },{ "BaselineClassTitle":"No", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"45" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"39" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"84" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Co-Morbidities", "BaselineMeasureDescription":"Diabetes: Yes or No", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Diabetes: Yes", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"19" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"21" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"40" } ] } } ] } },{ "BaselineClassTitle":"Diabetes: No", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"147" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"134" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"281" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Co-Morbidities", "BaselineMeasureDescription":"Past or Current Smoker: Yes or No", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Past or Current Smoker:Yes", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"89" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"99" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"188" } ] } } ] } },{ "BaselineClassTitle":"Past or Current Smoker:No", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"77" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"56" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"133" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Steroids Administered", "BaselineMeasureDescription":"Steroids Administered: Yes or No", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Steroids Administered: Yes", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"125" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"122" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"247" } ] } } ] } },{ "BaselineClassTitle":"Steroids Administered: No", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"41" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"33" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"74" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Insulin Infusion", "BaselineMeasureDescription":"Insulin Infusion: Yes or No", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Insulin Infusion: Yes", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"47" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"42" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"89" } ] } } ] } },{ "BaselineClassTitle":"Insulin Infusion: No", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"119" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"113" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"232" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Declaration of Death to Initial Intervention, Hours", "BaselineMeasureDescription":"Interval from declaration of brain death to the initial intervention.", "BaselineMeasureParamType":"Median", "BaselineMeasureDispersionType":"Inter-Quartile Range", "BaselineMeasureUnitOfMeasure":"hours", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5.8", "BaselineMeasurementLowerLimit":"4.2", "BaselineMeasurementUpperLimit":"8.8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"7.3", "BaselineMeasurementLowerLimit":"5.0", "BaselineMeasurementUpperLimit":"12.1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"6.5", "BaselineMeasurementLowerLimit":"4.7", "BaselineMeasurementUpperLimit":"10.4" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Initial Intervention to Cross Clamp", "BaselineMeasureDescription":"3 Groups:\n\n5.9-24.0 hours\n24.1-39.5 hours\nData Not Available", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Intervention to Cross Clamp: 5.9-24.0 hours", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"123" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"115" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"238" } ] } } ] } },{ "BaselineClassTitle":"Intervention to Cross Clamp: 24.1-39.5 hours", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"35" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"25" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"60" } ] } } ] } },{ "BaselineClassTitle":"Intervention to Cross Clamp: Data not available", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"15" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"23" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Vasopressor Score", "BaselineMeasureDescription":"A numerical score calculated for number and dose of Vasopressors in use. The score is calculated using the following formula (from Zuppa AF et. al.CRIT CARE MED 2004 Vol. 32 p 2318-2322):\n\nVasopressor Score= (dopamine dose[y=ug/kg/min x 1]) + (dobutamine dose [ug/kg/min] x 1) + (epinephrine dose [ug/kg/min] x100) + (norepinephrine dose [ug/kg/min] x 100) + (phenylephrine dose [ug/kg/min] x 100).\n\nThe range for our study was 0-4900 with higher doses indicating higher vasopressor use in the donor.\n\nData missing per group:\n\nNo RIPC=2 RIPC=2", "BaselineMeasurePopulationDescription":"Data missing for 2 participants in each arm of the study.", "BaselineMeasureParamType":"Median", "BaselineMeasureDispersionType":"Inter-Quartile Range", "BaselineMeasureUnitOfMeasure":"units on a scale", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"164" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"153" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"317" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"100", "BaselineMeasurementLowerLimit":"0", "BaselineMeasurementUpperLimit":"925.0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"16.0", "BaselineMeasurementLowerLimit":"0", "BaselineMeasurementUpperLimit":"600" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"37", "BaselineMeasurementLowerLimit":"0", "BaselineMeasurementUpperLimit":"800" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"P:F ratio", "BaselineMeasureDescription":"P:F ratio: Ratio of partial pressure of arterial oxygen: fraction of inspired oxygen.\n\nMissing data:\n\nNo RIPC=2 RIPC=4", "BaselineMeasureParamType":"Median", "BaselineMeasureDispersionType":"Inter-Quartile Range", "BaselineMeasureUnitOfMeasure":"ratio", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"249.8", "BaselineMeasurementLowerLimit":"154.8", "BaselineMeasurementUpperLimit":"393.0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"244.0", "BaselineMeasurementLowerLimit":"152.0", "BaselineMeasurementUpperLimit":"387.5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"248", "BaselineMeasurementLowerLimit":"154.3", "BaselineMeasurementUpperLimit":"389.3" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Ventricular Ejection Fraction", "BaselineMeasureDescription":"Ventricular Ejection Fraction\n\nMissing data:\n\nNo RIPC: 39 RIPC: 31", "BaselineMeasureParamType":"Median", "BaselineMeasureDispersionType":"Inter-Quartile Range", "BaselineMeasureUnitOfMeasure":"proportion ejection fraction", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0.6", "BaselineMeasurementLowerLimit":"0.55", "BaselineMeasurementUpperLimit":"0.65" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0.59", "BaselineMeasurementLowerLimit":"0.49", "BaselineMeasurementUpperLimit":"0.65" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0.6", "BaselineMeasurementLowerLimit":"0.52", "BaselineMeasurementUpperLimit":"0.65" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Serum Chemistry: Creatinine", "BaselineMeasureDescription":"Serum Chemistry: Creatinine, mg/dL\n\nMissing data:\n\nNo RIPC=3 RIPC=2", "BaselineMeasureParamType":"Median", "BaselineMeasureDispersionType":"Inter-Quartile Range", "BaselineMeasureUnitOfMeasure":"mg/dL", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1.0", "BaselineMeasurementLowerLimit":"0.7", "BaselineMeasurementUpperLimit":"1.6" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1.1", "BaselineMeasurementLowerLimit":"0.8", "BaselineMeasurementUpperLimit":"1.4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1.06", "BaselineMeasurementLowerLimit":"0.8", "BaselineMeasurementUpperLimit":"1.4" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Serum Chemistry: Lactate", "BaselineMeasureDescription":"Serum Chemistry: Lactate, mg/dL\n\nMissing data:\n\nNo RIPC= 31 RIPC= 21", "BaselineMeasureParamType":"Median", "BaselineMeasureDispersionType":"Inter-Quartile Range", "BaselineMeasureUnitOfMeasure":"mg/dL", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1.5", "BaselineMeasurementLowerLimit":"1.1", "BaselineMeasurementUpperLimit":"2.4" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1.6", "BaselineMeasurementLowerLimit":"1.1", "BaselineMeasurementUpperLimit":"2.4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1.6", "BaselineMeasurementLowerLimit":"1.1", "BaselineMeasurementUpperLimit":"2.4" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Serum Chemistry: Troponin I", "BaselineMeasureDescription":"Serum Chemistry: Troponin I, ng/ml\n\nMissing data:\n\nNo RIPC= 37 RIPC= 29", "BaselineMeasureParamType":"Median", "BaselineMeasureDispersionType":"Inter-Quartile Range", "BaselineMeasureUnitOfMeasure":"ng/ml", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"166" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"321" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0.28", "BaselineMeasurementLowerLimit":"0.04", "BaselineMeasurementUpperLimit":"1.07" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0.31", "BaselineMeasurementLowerLimit":"0.07", "BaselineMeasurementUpperLimit":"1.25" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0.29", "BaselineMeasurementLowerLimit":"0.05", "BaselineMeasurementUpperLimit":"1.18" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Number of Organs Recovered Per Donor", "OutcomeMeasureDescription":"Number of organs recovered per organ donor", "OutcomeMeasurePopulationDescription":"Subjects were organ donors enrolled in this multicenter study", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"organs recovered per donor", "OutcomeMeasureTimeFrame":"At time of organ recovery, up to 1 day", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"No RIPC", "OutcomeGroupDescription":"The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"RIPC", "OutcomeGroupDescription":"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.\n\nRIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"166" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"155" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.79", "OutcomeMeasurementSpread":"1.73" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.60", "OutcomeMeasurementSpread":"1.84" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Sample Size and Power estimation: A sample size of at least 150 donors in each arm was estimated to provide 80% power to detect a difference of 0.44 of an organ recovered and 0.48 of an organ transplanted per donor. The difference criterion was chosen based on published results achieved with hormonal resuscitation in organ donors. 6 Pooled standard deviations (organs recovered: 1.35; organs transplanted: 1.5) from data of two OPOs were used.", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.38", "OutcomeAnalysisPValueComment":"This is an unadjusted comparison. P value < 0.05", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisStatisticalComment":"Adjusted analyses for the RIPC effect are provided below.", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"-0.08", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.37", "OutcomeAnalysisCIUpperLimit":"0.21", "OutcomeAnalysisEstimateComment":"0.08 less organs per donor in the RIPC group." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Organs Transplanted Per Donor", "OutcomeMeasureDescription":"Number of organs transplanted from each organ donor", "OutcomeMeasurePopulationDescription":"Subjects were organ donors enrolled in this multicenter study", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Organs transplanted from each donor", "OutcomeMeasureTimeFrame":"Within 24 hours of organ recovery", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"No RIPC", "OutcomeGroupDescription":"The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"RIPC", "OutcomeGroupDescription":"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.\n\nRIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"166" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"155" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.41", "OutcomeMeasurementSpread":"1.90" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.31", "OutcomeMeasurementSpread":"1.94" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Sample Size A sample size of at least 150 donors in each arm was estimated to provide 80% power to detect a difference of 0.44 of an organ recovered and 0.48 of an organ transplanted per donor. The difference criterion was chosen based on published results achieved with hormonal resuscitation in organ donors. 6 Pooled standard deviations (organs recovered: 1.35; organs transplanted: 1.5) from data of two OPOs were used.", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.70", "OutcomeAnalysisPValueComment":"This is an unadjusted analysis. P < 0.05", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisStatisticalComment":"Adjusted analyses are provided below.", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"-0.03", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.33", "OutcomeAnalysisCIUpperLimit":"0.26", "OutcomeAnalysisEstimateComment":"0.03 less organs per donor in the RIPC group." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Vasopressor Score", "OutcomeMeasureDescription":"Changes in the following: Vasopressor usage, serum Lactate, Creatinine clearance, arterial oxygen pressure:fraction of inspired oxygen (P:F) ratios, Lung Compliance, Cardiac biomarkers, ejection fraction (EF) from 2-dimensional Echocardiogram.\n\nHere we will present data for the change in vasopressor use evaluated using a vasopressor score.\n\nA numerical score calculated for number and dose of Vasopressors in use. The score is calculated using the following formula (from Zuppa AF et. al.CRIT CARE MED 2004 Vol. 32 p 2318-2322):\n\nVasopressor Score= (dopamine dose[y=ug/kg/min x 1]) + (dobutamine dose [ug/kg/min] x 1) + (epinephrine dose [ug/kg/min] x100) + (norepinephrine dose [ug/kg/min] x 100) + (phenylephrine dose [ug/kg/min] x 100).\n\nThe range for our study was 0-4900 with higher doses indicating higher vasopressor use in the donor.", "OutcomeMeasurePopulationDescription":"Donors in whom vasopressor agent and dose were described in the OPO records before intervention and prior to aortic cross clamp.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Inter-Quartile Range", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"Vasopressor score was determined before aortic cross clamp minus the value prior to the first intervention, an average of 19 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"No RIPC", "OutcomeGroupDescription":"The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"RIPC", "OutcomeGroupDescription":"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.\n\nRIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"158" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"141" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-15.60", "OutcomeMeasurementLowerLimit":"-600", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-6.00", "OutcomeMeasurementLowerLimit":"-400", "OutcomeMeasurementUpperLimit":"0" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.63", "OutcomeAnalysisPValueComment":"P<0.05", "OutcomeAnalysisStatisticalMethod":"Wilcoxon (Mann-Whitney)", "OutcomeAnalysisStatisticalComment":"This is an unadjusted comparison" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Serum Lactate", "OutcomeMeasureDescription":"Change in serum lactate levels (mg/dL) from before intervention to the final value", "OutcomeMeasurePopulationDescription":"Donors in whom at least two serum lactate levels (one before and one after the initial intervention) were available", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Inter-Quartile Range", "OutcomeMeasureUnitOfMeasure":"mg/dL", "OutcomeMeasureTimeFrame":"Subjects will be followed from admission to explantation, an average of 4.5 days", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"No RIPC", "OutcomeGroupDescription":"The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"RIPC", "OutcomeGroupDescription":"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.\n\nRIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"127" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"126" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.12", "OutcomeMeasurementLowerLimit":"-40", "OutcomeMeasurementUpperLimit":"0.70" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.20", "OutcomeMeasurementLowerLimit":"-40", "OutcomeMeasurementUpperLimit":"0.60" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.86", "OutcomeAnalysisStatisticalMethod":"Wilcoxon (Mann-Whitney)" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Creatinine Clearance", "OutcomeMeasureDescription":"Change in creatinine clearance (mL/min by Cockcroft-Gault method) from before intervention to terminal value", "OutcomeMeasurePopulationDescription":"Donors in whom two serum creatinine values (one before intervention and another after the initial intervention) are available.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Inter-Quartile Range", "OutcomeMeasureUnitOfMeasure":"mL/min", "OutcomeMeasureTimeFrame":"Subjects will be followed from admission to explantation, an average of 4.5 days", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"No RIPC", "OutcomeGroupDescription":"The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"RIPC", "OutcomeGroupDescription":"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.\n\nRIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"155" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"145" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"-8.1", "OutcomeMeasurementUpperLimit":"9.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"-10.6", "OutcomeMeasurementUpperLimit":"14.4" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.55", "OutcomeAnalysisPValueComment":"P<0.05", "OutcomeAnalysisStatisticalMethod":"Wilcoxon (Mann-Whitney)", "OutcomeAnalysisStatisticalComment":"This is an unadjusted comparison" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in P:F Ratio", "OutcomeMeasureDescription":"Change in ratio of arterial oxygen pressure:fraction inspired oxygen ratio from before intervention to terminal value", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Inter-Quartile Range", "OutcomeMeasureUnitOfMeasure":"ratio", "OutcomeMeasureTimeFrame":"Subjects will be followed from admission to explantation, an average of 4.5 days", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"No RIPC", "OutcomeGroupDescription":"The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.\n\nAny discrepancy in the number of participants is attributed to missing data for some participants" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"RIPC", "OutcomeGroupDescription":"The donors assigned to this group would receive two RIPC interventions. The first occurs immediately after brain death declaration and consent for organ donation. The second one immediately before of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.\n\nRIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention occurs at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb.\n\nAny discrepancy in the number of participants is attributed to missing data for some participants" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"152" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"142" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.5", "OutcomeMeasurementLowerLimit":"-57.3", "OutcomeMeasurementUpperLimit":"86.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.05", "OutcomeMeasurementLowerLimit":"-74.3", "OutcomeMeasurementUpperLimit":"96.2" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.55", "OutcomeAnalysisPValueComment":"P<0.05", "OutcomeAnalysisStatisticalMethod":"Wilcoxon (Mann-Whitney)", "OutcomeAnalysisStatisticalComment":"This is an unadjusted comparison" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Dynamic Compliance", "OutcomeMeasureDescription":"Change in dynamic compliance of the lung from before intervention to terminal value\n\nCdyn = Dynamic compliance; Vt = tidal volume; PIP = Peak inspiratory pressure (the maximum pressure during inspiration); PEEP = Positive End Expiratory Pressure:\n\nCdyn= Vt/PIP - PEEP", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Inter-Quartile Range", "OutcomeMeasureUnitOfMeasure":"L/cm H20", "OutcomeMeasureTimeFrame":"Subjects will be followed from admission to explantation, an average of 4.5 days", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"No RIPC", "OutcomeGroupDescription":"The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization.\n\nAny discrepancy in the number of participants is attributed to missing data for some participants" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"RIPC", "OutcomeGroupDescription":"The donors assigned to this group would receive two RIPC interventions. The first occurs immediately after brain death declaration and consent for organ donation. The second one immediately before of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.\n\nRIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention occurs at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb.\n\nAny discrepancy in the number of participants is attributed to missing data for some participants" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"123" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"123" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.30", "OutcomeMeasurementLowerLimit":"-2.0", "OutcomeMeasurementUpperLimit":"7.6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.20", "OutcomeMeasurementLowerLimit":"-1.8", "OutcomeMeasurementUpperLimit":"8.1" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.48", "OutcomeAnalysisPValueComment":"P<0.05", "OutcomeAnalysisStatisticalMethod":"Wilcoxon (Mann-Whitney)", "OutcomeAnalysisStatisticalComment":"This is an unadjusted comparison" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Troponins", "OutcomeMeasureDescription":"Change in serum troponin I (ng/mL) from before intervention to terminal value", "OutcomeMeasurePopulationDescription":"Only donors in whom two troponin I values (one before intervention and another after the initial intervention) were available were included in this analysis", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Inter-Quartile Range", "OutcomeMeasureUnitOfMeasure":"ng/mL", "OutcomeMeasureTimeFrame":"Subjects will be followed from admission to explantation, an average of 4.5 days", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"No RIPC", "OutcomeGroupDescription":"The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"RIPC", "OutcomeGroupDescription":"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.\n\nRIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"122" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"119" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.04", "OutcomeMeasurementLowerLimit":"-0.38", "OutcomeMeasurementUpperLimit":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.09", "OutcomeMeasurementLowerLimit":"-0.69", "OutcomeMeasurementUpperLimit":"-0.01" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.04", "OutcomeAnalysisPValueComment":"P<0.05", "OutcomeAnalysisStatisticalMethod":"Wilcoxon (Mann-Whitney)", "OutcomeAnalysisStatisticalComment":"This is an unadjusted comparison" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Pulsatile Perfusion Flow", "OutcomeMeasureDescription":"Perfusate flow (mL/min) in machine perfused kidneys.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"mL/min", "OutcomeMeasureTimeFrame":"Up to 24 hours of machine perfusion", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"No RIPC", "OutcomeGroupDescription":"Kidneys in this group were recovered from donors in the No RIPC arm. Decisions regarding which kidneys were not and were pumped were made by the OPO.\n\nAny discrepancy in the number of participants is attributed to missing data for some subjects." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"RIPC", "OutcomeGroupDescription":"Kidneys in this group were recovered from donors in the RIPC arm. Decisions regarding which kidneys were not and were pumped were made by the OPO.\n\nAny discrepancy in the number of participants is attributed to missing data for some subjects." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"49" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"32" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Flow at 1 hour, mL/min", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"98.58", "OutcomeMeasurementSpread":"32.41" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"89.42", "OutcomeMeasurementSpread":"38.31" } ] } } ] } },{ "OutcomeClassTitle":"4 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"105.28", "OutcomeMeasurementSpread":"23.75" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"104.03", "OutcomeMeasurementSpread":"40.66" } ] } } ] } },{ "OutcomeClassTitle":"8 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"117.98", "OutcomeMeasurementSpread":"28.86" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"94.21", "OutcomeMeasurementSpread":"32.64" } ] } } ] } },{ "OutcomeClassTitle":"12 hours", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"115.19", "OutcomeMeasurementSpread":"20.07" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"106.36", "OutcomeMeasurementSpread":"32.55" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.53", "OutcomeAnalysisPValueComment":"P<0.05", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisStatisticalComment":"Final flow was modeled on RIPC and adjusted for donor stratum and duration of perfusion", "OutcomeAnalysisParamType":"Median Difference (Final Values)", "OutcomeAnalysisParamValue":"-4.7", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-10.1", "OutcomeAnalysisCIUpperLimit":"19.5", "OutcomeAnalysisEstimateComment":"Data shown above is the the adjusted mean difference in final flow in RIPC group" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Six Month Hospital Free Survival of All Organ Recipients", "OutcomeMeasureDescription":"Six month hospital-free survival was defined as the number of days recipients survived following the initial discharge after the transplant.", "OutcomeMeasurePopulationDescription":"Recipients of all organs from donors enrolled in the two arms", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Inter-Quartile Range", "OutcomeMeasureUnitOfMeasure":"days", "OutcomeMeasureTimeFrame":"6 months post-transplant", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"No RIPC", "OutcomeGroupDescription":"The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"RIPC", "OutcomeGroupDescription":"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.\n\nRIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"482" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"456" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"172", "OutcomeMeasurementLowerLimit":"165", "OutcomeMeasurementUpperLimit":"174" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"171", "OutcomeMeasurementLowerLimit":"165", "OutcomeMeasurementUpperLimit":"174" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.97", "OutcomeAnalysisStatisticalMethod":"Wilcoxon (Mann-Whitney)" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Delayed Graft Function (DGF) of Kidney Recipients.", "OutcomeMeasureDescription":"DGF is defined as the need for dialysis within the first week post transplantation.", "OutcomeMeasurePopulationDescription":"Kidney recipients of donors in each arm.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"7 days post-transplant", "OutcomeMeasureTypeUnitsAnalyzed":"Kidney Recipients", "OutcomeMeasureDenomUnitsSelected":"Kidney Recipients", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"No RIPC", "OutcomeGroupDescription":"The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"RIPC", "OutcomeGroupDescription":"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.\n\nRIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"166" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"155" } ] } },{ "OutcomeDenomUnits":"Kidney Recipients", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"247" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"235" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"DGF: Yes", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"45" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"51" } ] } } ] } },{ "OutcomeClassTitle":"DGF: No", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"202" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"184" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.07", "OutcomeAnalysisPValueComment":"Adjusted analysis with recipient age as a continuous variable, sex, race as black versus not black, body mass index, diabetes, hypertension,antigen mismatches, donor age as a continuous variable and trial site.", "OutcomeAnalysisStatisticalMethod":"Chi-squared", "OutcomeAnalysisParamType":"Odds Ratio (OR)", "OutcomeAnalysisParamValue":"1.62", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.95", "OutcomeAnalysisCIUpperLimit":"2.76" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.36", "OutcomeAnalysisPValueComment":"Unadjusted analysis", "OutcomeAnalysisStatisticalMethod":"Chi-squared" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Pulsatile Perfusion Parameters", "OutcomeMeasureDescription":"Perfusate resistance (mm Hg/mL/min) in machine perfused kidneys.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Resistance, mm Hg/mL/min", "OutcomeMeasureTimeFrame":"Up to 24 hours of machine perfusion", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"No Remote Ischemic Preconditioning", "OutcomeGroupDescription":"The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Remote Ischemic Preconditioning", "OutcomeGroupDescription":"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.\n\nRIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"49" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"32" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Resistance at 1 hour, mL/min", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.29", "OutcomeMeasurementSpread":"0.12" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.38", "OutcomeMeasurementSpread":"0.30" } ] } } ] } },{ "OutcomeClassTitle":"Resistance at 4 hours, mL/min", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.25", "OutcomeMeasurementSpread":"0.10" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.31", "OutcomeMeasurementSpread":"0.23" } ] } } ] } },{ "OutcomeClassTitle":"Resistance at 8 hours, mL/min", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.22", "OutcomeMeasurementSpread":"0.09" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.33", "OutcomeMeasurementSpread":"0.23" } ] } } ] } },{ "OutcomeClassTitle":"Resistance at 12 hours, mL/min", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.22", "OutcomeMeasurementSpread":"0.08" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.29", "OutcomeMeasurementSpread":"0.22" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.006", "OutcomeAnalysisStatisticalMethod":"Regression, Linear", "OutcomeAnalysisStatisticalComment":"Final resistance was modeled on RIPC and adjusted for donor stratum and duration of perfusion.", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"0.1", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.03", "OutcomeAnalysisCIUpperLimit":"0.17", "OutcomeAnalysisEstimateComment":"Data shown above is the adjusted mean difference in final resistance in the RIPC group." } ] } },{ "OutcomeMeasureType":"Post-Hoc", "OutcomeMeasureTitle":"Acute Kidney Rejection", "OutcomeMeasureDescription":"Diagnosis of rejection as documented in the recipient records in the Scientific Registry of Transplant Recipients (SRTR).", "OutcomeMeasurePopulationDescription":"This outcome was examined in recipients of in SRTR that received kidneys from donors in the RIPNOD trial", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"6 months after kidney transplantation", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"No RIPC", "OutcomeGroupDescription":"The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"RIPC", "OutcomeGroupDescription":"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.\n\nRIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"247" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"235" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Rejection: Yes", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"17" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"13" } ] } } ] } },{ "OutcomeClassTitle":"Rejection: No", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"230" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"222" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.50", "OutcomeAnalysisStatisticalMethod":"Fisher Exact", "OutcomeAnalysisStatisticalComment":"This is an unadjusted comparison" } ] } },{ "OutcomeMeasureType":"Post-Hoc", "OutcomeMeasureTitle":"Graft Survival", "OutcomeMeasureDescription":"Kaplan-Meier estimates of 6, 12 and 24 months survival of all grafts", "OutcomeMeasurePopulationDescription":"All grafts transplanted from donors in the RIPNOD trial and in whom recipient records are available in SRTR were included in this analysis. Graft loss is defined as retransplantation or death during the 24 months post-transplant.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of all grafts", "OutcomeMeasureTimeFrame":"Graft survival was monitored from transplant date until retransplantation or death up to 2 years as in SRTR data file October 2015", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"No RIPC", "OutcomeGroupDescription":"The donors assigned to this group will receive standard of care of management of brain death donors in each organ procurement organization." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"RIPC", "OutcomeGroupDescription":"The donors assigned to this group would receive two RIPC interventions. The first one would occur immediately after brain death declaration and consent for organ donation. The second one would occur immediately before commencement of organ recovery. At each occasion RIPC would be induced by 4 cycles of mid-thigh inflation of tourniquet for 5 min followed by deflation for 5 minutes.\n\nRIPC (Remote Ischemic Preconditioning): Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"523" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"489" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"6 months graft survival", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"91.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"94.6" } ] } } ] } },{ "OutcomeClassTitle":"12 months", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"88.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"92.2" } ] } } ] } },{ "OutcomeClassTitle":"24 months", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"82.2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"87.8" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.03", "OutcomeAnalysisStatisticalMethod":"Log Rank", "OutcomeAnalysisStatisticalComment":"This is an unadjusted comparison" } ] } },{ "OutcomeMeasureType":"Post-Hoc", "OutcomeMeasureTitle":"Death-Censored Kidney Graft Survival at 6, 12 and 24 Months", "OutcomeMeasureDescription":"kidney graft survival censored for death with functioning graft", "OutcomeMeasurePopulationDescription":"Included were kidneys transplanted alone or with pancreas. All kidney grafts transplanted from donors in the RIPNOD trial and in whom recipient records are available in SRTR were included in this analysis. Kidney graft loss is defined as loss of functioning graft or retransplantation during the 24 months post-transplant.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Kidney graft survival was monitored from transplant date until retransplantation or death up to 2 years as in SRTR data file October 2015", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"No RIPC", "OutcomeGroupDescription":"Kidneys in this group were recovered from donors in the No RIPC arm." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"RIPC", "OutcomeGroupDescription":"Kidneys in this group were recovered from donors in the RIPC arm." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"247" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"235" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Death censored kidney survival: 6 months", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"94.2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"99.1" } ] } } ] } },{ "OutcomeClassTitle":"12 months", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"92.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"96.8" } ] } } ] } },{ "OutcomeClassTitle":"24 months", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"87.4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"96" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.01", "OutcomeAnalysisStatisticalMethod":"Log Rank", "OutcomeAnalysisStatisticalComment":"Results of adjusted Cox proportional hazard analyses for six month death-censored kidney graft survival are shown below", "OutcomeAnalysisParamType":"Cox Proportional Hazard", "OutcomeAnalysisParamValue":"0.19", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.04", "OutcomeAnalysisCIUpperLimit":"0.90", "OutcomeAnalysisEstimateComment":"The proportional hazard ratio favors RIPC group" } ] } },{ "OutcomeMeasureType":"Post-Hoc", "OutcomeMeasureTitle":"Recipient Survival", "OutcomeMeasureDescription":"Kaplan-Meier estimates of 6, 12 and 24 months survival of all recipients", "OutcomeMeasurePopulationDescription":"All recipients of organs from donors in the RIPNOD trial and in whom recipient records are available in SRTR were included in this analysis", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Recipient survival was monitored from transplant date until death up to 2 years as in SRTR data file October 2015", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"No RIPC", "OutcomeGroupDescription":"The recipients in this group received one or more organs from donors in the No RIPC arm of the RIPNOD trial." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"RIPC", "OutcomeGroupDescription":"The recipients in this group received one or more organs from donors in the RIPC arm of the RIPNOD trial" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"494" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"458" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Recipient survival: 6 months", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"92" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"94.1" } ] } } ] } },{ "OutcomeClassTitle":"12 months", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"90.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"91.5" } ] } } ] } },{ "OutcomeClassTitle":"24 months", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"84.4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"87.1" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.37", "OutcomeAnalysisStatisticalMethod":"Log Rank", "OutcomeAnalysisStatisticalComment":"This is an unadjusted comparison" } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsDescription":"Adverse events to be collected were not identified or defined a priori. In donors, data were collected from enrollment to organ recovery; recipient data for DGF in kidney recipients were abstracted from transplantation to last follow up to 2 years in SRTR. Lack of information in SRTR precluded analyses regarding the severity of DGF. Submitted followup data was available at 6, 12 and 24 months in 97.5%, 75.5% and 38.8% of recipients, respectively. Updated SRTR recipient data has been requested.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"No RIPC, Kidney Recipients", "EventGroupDescription":"Recipients in this group received kidneys from donors who did not receive remote ischemic preconditioning (No RIPC group)", "EventGroupSeriousNumAffected":"45", "EventGroupSeriousNumAtRisk":"247", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"247" },{ "EventGroupId":"EG001", "EventGroupTitle":"RIPC, Kidney Recipients", "EventGroupDescription":"Recipients in this group received kidneys from donors who received two RIPC interventions", "EventGroupSeriousNumAffected":"51", "EventGroupSeriousNumAtRisk":"235", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"235" },{ "EventGroupId":"EG002", "EventGroupTitle":"No RIPC, All Organ Recipients", "EventGroupDescription":"Recipients in this group received organs from donors who did not receive remote ischemic preconditioning (No RIPC)", "EventGroupSeriousNumAffected":"81", "EventGroupSeriousNumAtRisk":"494", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"494" },{ "EventGroupId":"EG003", "EventGroupTitle":"RIPC, All Organ Recipients", "EventGroupDescription":"Recipients in this group received organs from donors who received two RIPC interventions", "EventGroupSeriousNumAffected":"54", "EventGroupSeriousNumAtRisk":"458", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"458" },{ "EventGroupId":"EG004", "EventGroupTitle":"No RIPC, Donors", "EventGroupDescription":"Donors in this group did not receive remote ischemic preconditioning (RIPC)", "EventGroupSeriousNumAffected":"8", "EventGroupSeriousNumAtRisk":"166", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"166" },{ "EventGroupId":"EG005", "EventGroupTitle":"RIPC, Donors", "EventGroupDescription":"Donors in this group received two RIPC interventions", "EventGroupSeriousNumAffected":"14", "EventGroupSeriousNumAtRisk":"155", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"155" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"DGF in kidney recipients", "SeriousEventOrganSystem":"Renal and urinary disorders", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventNotes":"DGF defined as dialysis within the first week after kidney transplant", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"45", "SeriousEventStatsNumAffected":"45", "SeriousEventStatsNumAtRisk":"247" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"51", "SeriousEventStatsNumAffected":"51", "SeriousEventStatsNumAtRisk":"235" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"0" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"0" },{ 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