{
  "FullStudy":{
    "Rank":218224,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01511120",
          "OrgStudyIdInfo":{
            "OrgStudyId":"2011/498"
          },
          "Organization":{
            "OrgFullName":"Haukeland University Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"The Effect on Fluid Balance After Cardiac Surgery After Use of Two Different Priming Protocols",
          "OfficialTitle":"Ringer`s Acetat Versus Balanced Hydroxyethyl-starch as Primesolution in the Heart-lung Maschine During Cardio-pulmonary-bypass. Postoperatively Fluid Balance and Cardiac Function"
        },
        "StatusModule":{
          "StatusVerifiedDate":"August 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"December 7, 2011",
          "StudyFirstSubmitQCDate":"January 17, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 18, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"May 11, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"May 12, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Haukeland University Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"\"The impact on fluid loading after cardiac surgery by use of two different priming solution\"\n\nFluid overloading with oedema formation is a regular finding following on-pump cardiac surgery and may contribute to postoperative organ dysfunction. Myocardial oedema has been reported to impair both systolic and diastolic function. An association between intraoperative fluid loading and postoperative adverse outcome has been demonstrated in cardiac patients.\n\nThe investigators have experience with the use of both colloides and combination fluids (hypertonic saline/colloides) in several experimental studies (pigs). In one animal study the investigators used colloides as an additive to the CPB-prime. The investigators observed reduced fluid leakage and less total tissue water in several organs.\n\nThe planned study includes patients scheduled for coronary artery bypass, and who have no co-morbidity. The patients will be randomized to receive either Tetraspan® (HES) or acetated Ringer`s solution in the CPB-prime. Accurate accounts of fluid additions, blood loss and diuresis will be kept. Determination of cardiac output (C.O.), intrathoracic blood volume (ITBV), extravascular lung water (EVLW) and global end diastolic volume (GEDV) will be monitored by use of the transpulmonary thermodilution technique PiCCO®plus system."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Coronary Heart Disease"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Supportive Care",
            "DesignMaskingInfo":{
              "DesignMasking":"Triple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"40",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Tetraspan",
                "ArmGroupType":"Active Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Tetraspan",
                    "Drug: acetated Ringer`s solution"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Tetraspan",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Tetraspan"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Tetraspan® (HES 130/0,42 , 6%),",
                    "B. Braun Medical AS",
                    "Kjernåsveien 13 B",
                    "3142 Vestskogen"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"acetated Ringer`s solution",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Tetraspan"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Reduction of organ edema and improved organ function",
                "PrimaryOutcomeDescription":"As a target of effect the investigators have chosen to study improvements for organ function.Indexed values for cardiac output(CI) measured by the PICCO system will be a parameter for heart function, andf lung function will be measured by EVLWI(extravascular lungwater index).paO2/FiO2-ratio and time spent in respirator.Additionally a strict account for fluid balance will be kept.",
                "PrimaryOutcomeTimeFrame":"6-hours postoperatively"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPatients undergoing CABG,\nEF(ejection fraction) more than 40%\n\nExclusion Criteria:\n\nReduced EF (less than 40%) EVF less than 30%,\nEstimated GFR less than 60%,\nBMI less than 18 or more than 32",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"80 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Hjerteavdelingen, thoraxkirurgisk seksjon, Haukeland Universitetssykehus",
                "LocationCity":"Bergen",
                "LocationZip":"5021",
                "LocationCountry":"Norway"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"29199540",
                "ReferenceType":"derived",
                "ReferenceCitation":"Svendsen ØS, Farstad M, Mongstad A, Haaverstad R, Husby P, Kvalheim VL. Is the use of hydroxyethyl starch as priming solution during cardiac surgery advisable? A randomized, single-center trial. Perfusion. 2018 Sep;33(6):483-489. doi: 10.1177/0267659117746235. Epub 2017 Dec 4."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M20444",
                "InterventionBrowseLeafName":"Pharmaceutical Solutions",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000006331",
                "ConditionMeshTerm":"Heart Diseases"
              },{
                "ConditionMeshId":"D000003327",
                "ConditionMeshTerm":"Coronary Disease"
              },{
                "ConditionMeshId":"D000003324",
                "ConditionMeshTerm":"Coronary Artery Disease"
              },{
                "ConditionMeshId":"D000017202",
                "ConditionMeshTerm":"Myocardial Ischemia"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000002318",
                "ConditionAncestorTerm":"Cardiovascular Diseases"
              },{
                "ConditionAncestorId":"D000014652",
                "ConditionAncestorTerm":"Vascular Diseases"
              },{
                "ConditionAncestorId":"D000001161",
                "ConditionAncestorTerm":"Arteriosclerosis"
              },{
                "ConditionAncestorId":"D000001157",
                "ConditionAncestorTerm":"Arterial Occlusive Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M5129",
                "ConditionBrowseLeafName":"Coronary Artery Disease",
                "ConditionBrowseLeafAsFound":"Coronary Heart Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M8002",
                "ConditionBrowseLeafName":"Heart Diseases",
                "ConditionBrowseLeafAsFound":"Heart Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M18089",
                "ConditionBrowseLeafName":"Myocardial Ischemia",
                "ConditionBrowseLeafAsFound":"Coronary Heart Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M5132",
                "ConditionBrowseLeafName":"Coronary Disease",
                "ConditionBrowseLeafAsFound":"Coronary Heart Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9126",
                "ConditionBrowseLeafName":"Ischemia",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15983",
                "ConditionBrowseLeafName":"Vascular Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3050",
                "ConditionBrowseLeafName":"Arteriosclerosis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3046",
                "ConditionBrowseLeafName":"Arterial Occlusive Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              }
            ]
          }
        }
      }
    }
  }
}