{
  "FullStudy":{
    "Rank":218206,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01511354",
          "OrgStudyIdInfo":{
            "OrgStudyId":"101653"
          },
          "Organization":{
            "OrgFullName":"Texas A&M University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"New Stable Isotope Method to Determine Protein Requirements in Critically Ill Children",
          "OfficialTitle":"Development of New Stable Isotope Method to Determine Protein Requirements in Critically Ill Children"
        },
        "StatusModule":{
          "StatusVerifiedDate":"October 2017",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2008"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"January 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 12, 2012",
          "StudyFirstSubmitQCDate":"January 17, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 18, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"October 10, 2017",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"October 11, 2017",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Marielle PKJ Engelen, PhD",
            "ResponsiblePartyInvestigatorTitle":"PhD",
            "ResponsiblePartyInvestigatorAffiliation":"Texas A&M University"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Texas A&M University",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Arkansas Children's Hospital Research Institute",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The need for certain components of food (i.e. protein) for critically ill children is not clear. It is important to have critically ill children fed adequately to prevent that their condition becomes worse or that recovery takes longer. Research methods used in the past to investigate the need for protein (Nitrogen Balance calculations), were not sensitive enough in severely ill children. The purpose of this study is to develop a new research method to determine the need for protein in severely ill children. In order to develop this new method, more information is needed on the way the body of these children uses protein in 24-hours. In the present study during 24-hours 8 children of age less than 18 years who are admitted to either the Pediatric ICU or the Cardiovascular ICU. Subjects will receive a standard nutrition, providing an age specific amount of protein (age ≤ 3: 2.52 protein g/kg BW.d; age 4-6: 1.8 protein g/kg BW.d; age > 10: 1.44 protein g/kg BW.d) via tube feeding. They will also receive a mixture of stable isotopes of amino to investigate protein behavior in the body (protein kinetics) both by infusion in their blood and together with the nutrition. Blood will be drawn every 60 minutes during the 24-hour period and the behavior of protein and the concentrations in blood of amino acids and urea will be measured. Urine will be collected to measure nitrogen balance. The investigators will compare the results of this nitrogen balance method with the results of the stable isotope method. PIM2, PRISM, SIRS criteria will be used to get information on the severity of illness of the subjects. Also body weight and length as well as body composition of the subjects will be measured at the start and after the 24-hour period. Body composition will be measured by Bioelectrical Impedance Spectroscopy. Endpoints of the study are net whole-body protein synthesis (protein balance), 24-hour pattern of protein balance, 24-hour urea production, 24-hour nitrogen balance, 24-hour contribution of arginine kinetics to whole body protein breakdown, 24-hour muscle protein breakdown, splanchnic amino acid extraction and plasma amino acid concentrations."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Critically Ill"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "critically ill children",
              "ICU",
              "24hr protein balance",
              "stable isotopes",
              "fed state"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"12",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Standard clinical care",
                "ArmGroupDescription":"Standard nutritional therapy and treatment"
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Whole body protein synthesis rate",
                "PrimaryOutcomeDescription":"Whole body protein synthesis rate in the fed state",
                "PrimaryOutcomeTimeFrame":"24 hours"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Whole body protein breakdown rate",
                "SecondaryOutcomeDescription":"Whole body protein breakdown rate in the fed state",
                "SecondaryOutcomeTimeFrame":"24 hours"
              },{
                "SecondaryOutcomeMeasure":"Whole body protein breakdown rate",
                "SecondaryOutcomeDescription":"Whole body myofibrillar protein breakdown rate in the fed state",
                "SecondaryOutcomeTimeFrame":"24 hours"
              },{
                "SecondaryOutcomeMeasure":"Whole body Arginine production rate",
                "SecondaryOutcomeDescription":"Net whole body arginine production rate in the fed state",
                "SecondaryOutcomeTimeFrame":"24 h"
              },{
                "SecondaryOutcomeMeasure":"Splanchnic amino acid extraction",
                "SecondaryOutcomeDescription":"Splanchnic amino acid extraction in the fed state",
                "SecondaryOutcomeTimeFrame":"24 hr"
              },{
                "SecondaryOutcomeMeasure":"Urea production",
                "SecondaryOutcomeDescription":"Whole body urea production in the fed state",
                "SecondaryOutcomeTimeFrame":"24 hr"
              },{
                "SecondaryOutcomeMeasure":"Plasma amino acid levels",
                "SecondaryOutcomeDescription":"Plasme amino acid level in the fed state",
                "SecondaryOutcomeTimeFrame":"24 hr"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nCritically ill children with age less than 18 years at the time of enrollment\nAdmitted to the Pediatric ICU or Cardiovascular ICU, with an expected stay of >72 hours\nOne arterial line (or umbilical arterial line) and one multi-lumen central venous line (or two peripheral venous catheters) in place.\nContinuous total parenteral nutrition or continuous enteral feeding (e.g. via nasogastric, nasoduodenal, gastric, jejunal tube) with standard nutrition appropriate for age and weight expected during admission.\nNo planned major changes or interventions (such as surgery) in the treatment and care of the patient from enrollment to completion of study period (end of 24-hour stable isotope infusion protocol).\nHemodynamic stable condition (with or without continuous inotropic medication) defined as ≤1 boluses of volume resuscitation for hypotension in 24 hour.\nNo significant loss of plasma/blood from wounds or drains, that may influence the results of the study, no chylothorax.\nInformed consent by parent(s) or LAR.\n\nExclusion Criteria:\n\nCongenital/acquired metabolic or endocrine disorders or hepatic or renal failure or anuria or oliguria.\nGastrointestinal obstructions or any condition that causes malabsorption.\nActive gastro-intestinal bleeding.\nFluid restriction (<100 ml/kg BW.day) making administration of intravenous and enteral stable isotopes impossible.\nAny other condition that according to the Principal Investigator or study physician would interfere with collecting study samples (for example isolation due to MRSA infection).",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MaximumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult"
            ]
          },
          "StudyPopulation":"Stable critically ill children admitted to the Pediatric Intensive Care Unit or Cardiovascular Intensive Care Unit of ACH",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Marielle P Engelen, PhD",
                "OverallOfficialAffiliation":"University of Arkansas",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Arkansas Children's Hospital",
                "LocationCity":"Little Rock",
                "LocationState":"Arkansas",
                "LocationZip":"72202",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"28089618",
                "ReferenceType":"derived",
                "ReferenceCitation":"de Betue CTI, Garcia Casal XC, van Waardenburg DA, Schexnayder SM, Joosten KFM, Deutz NEP, Engelen MPKJ. 24-Hour protein, arginine and citrulline metabolism in fed critically ill children - A stable isotope tracer study. Clin Nutr. 2017 Jun;36(3):876-887. doi: 10.1016/j.clnu.2016.12.023. Epub 2017 Jan 4."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000016638",
                "ConditionMeshTerm":"Critical Illness"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000020969",
                "ConditionAncestorTerm":"Disease Attributes"
              },{
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M17593",
                "ConditionBrowseLeafName":"Critical Illness",
                "ConditionBrowseLeafAsFound":"Critically Ill",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M21284",
                "ConditionBrowseLeafName":"Disease Attributes",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}