{
  "FullStudy":{
    "Rank":217841,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01516138",
          "OrgStudyIdInfo":{
            "OrgStudyId":"XJcuiqin_2012"
          },
          "Organization":{
            "OrgFullName":"Xijing Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Benefits of GIK in Cardiac Surgery Patients",
          "OfficialTitle":"Myocardial Protection of Glucose - Insulin - Potassium in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass"
        },
        "StatusModule":{
          "StatusVerifiedDate":"July 2014",
          "OverallStatus":"Active, not recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"March 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"February 2022",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 8, 2012",
          "StudyFirstSubmitQCDate":"January 23, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"October 30, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"October 31, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Xijing Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to evaluate the effects of modified glucose - insulin - potassium (GIK) therapy in cardiac surgery patients undergoing cardiopulmonary bypass (CPB).",
          "DetailedDescription":"Cardiopulmonary bypass (CPB) is a necessary technique to maintain the circulation during cardiac surgery. But CPB itself is associated with a series of problems of organs, such as hyperglycemia induced by neuroendocrine stress. The research showed that hyperglycemia induced by stress would cause a worsened hospital outcome for patients undergoing cardiac surgery. Intraoperative and postoperative glucose control is beneficial for patients.\n\nIt has been for more than 40 year since the first application of glucose - insulin - potassium (GIK) in cardiac surgery but the clinical application of GIK shows controversial results. The beginning time of application and the ratio of glucose and insulin may be the key reasons for the controversy. In our pilot trial of 40 valve replacement cases, we found that perioperative treatment of GIK with an insulin-glucose ratio of 1:3 showed beneficial effects during heart surgery. Therefore, the investigators are planning to continue to test this modified GIK regimen for more heart surgery patients and determine whether GIK may have cardioprotective effects on patients undergoing CPB surgery.\n\nMyocardial biopsies for biological mechanism analysis will be performed prior to CPB, 15 min after aortic cross clamp application and 15 min after reperfusion only in a small cohort. Myocardial biopsies will be snap frozen or fixed."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Cardiac Surgery",
              "Cardiopulmonary Bypass"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Glucose-insulin-potassium",
              "Cardiac surgery"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Triple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"930",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"GIK",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"glucose-insulin-potassium (GIK) consists of 20% glucose (200 g/L), 66.7 U/L regular insulin and 80 mmol/L potassium chloride (KCl).",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: GIK"
                  ]
                }
              },{
                "ArmGroupLabel":"Control",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"6.12 g/L sodium acetate, 5.85 g/L sodium chloride, 0.3 g/L potassium chloride and 0.33 g/L calcium chloride",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Control"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"GIK",
                "InterventionDescription":"Intravenous solution was started at about 10 minutes before general anesthesia, running at a rate of 1 mL/kg/h for 12.5 hours.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "GIK"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Glucose-insulin-potassium"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Control",
                "InterventionDescription":"Intravenous solution was started at about 10 minutes before general anesthesia, running at a rate of 1 mL/kg/h for 12.5 hours.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Control"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Balanced salt solution"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Number of participants of the major adverse cardiac events",
                "PrimaryOutcomeDescription":"The composite of major adverse cardiac events included acute myocardial infarction, cardiac arrest with successful resuscitation, low cardiac output syndrome, congestive heart failure, arrhythmia and all-cause death.",
                "PrimaryOutcomeTimeFrame":"Stay in hospital"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"mortality",
                "SecondaryOutcomeTimeFrame":"until the study ends"
              },{
                "SecondaryOutcomeMeasure":"Length of stay in intensive care unit and hospital",
                "SecondaryOutcomeDescription":"Length of stay in intensive care unit and hospital",
                "SecondaryOutcomeTimeFrame":"Stay in intensive care unit and hospital"
              },{
                "SecondaryOutcomeMeasure":"Number of patients of postoperative complications",
                "SecondaryOutcomeDescription":"Postoperative complications included prolonged ventilation, the use of inotropes, sepsis/infection, renal complications, stroke and reoperation.",
                "SecondaryOutcomeTimeFrame":"Stay in hospital"
              }
            ]
          },
          "OtherOutcomeList":{
            "OtherOutcome":[
              {
                "OtherOutcomeMeasure":"Left ventricular ejection fraction (LVEF)",
                "OtherOutcomeTimeFrame":"24h after operation and before discharge"
              },{
                "OtherOutcomeMeasure":"Creatine kinase-myocardial bands (CK-MB)",
                "OtherOutcomeTimeFrame":"during 48 h after surgery"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nBetween 18 and 70 years of age\nElective cardiac surgery with first time cardiopulmonary bypass\nLeft ventricular ejection fraction(LVEF) ≥ 30%\nInformed agreement signed\n\nExclusion Criteria:\n\nPrevious cardiac surgery\nEmergent surgery\nCardiac surgery without the use of cardiopulmonary bypass\nDiabetes mellitus\nSevere renal insufficiency\nSevere respiratory insufficiency\nSerious preoperative illness (sepsis, active infection or active malignancy requiring treatment)\nPregnant woman or positive pregnancy test\nHistory of drug abuse\nSubject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion\nEnrollment in another clinical study\nLack of informed consent",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"70 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Dinghua Yi, MD,PhD",
                "OverallOfficialAffiliation":"Deparment of cardiovascular surgery, XiJing hospital, Fourth Military Medical University",
                "OverallOfficialRole":"Study Chair"
              },{
                "OverallOfficialName":"Qin Cui, MD,PhD",
                "OverallOfficialAffiliation":"Deparment of cardiovascular surgery,XiJing hospital,Fourth Military Medical University",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Jia Li, MD,PhD",
                "OverallOfficialAffiliation":"Deparment of Physiology, Fourth Military Medical University",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Feng Gao, MD,PhD",
                "OverallOfficialAffiliation":"Deparment of Physiology, Fourth Military Medical University",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Kun Zhao, MD",
                "OverallOfficialAffiliation":"Deparment of cardiovascular surgery, XiJing hospital,Fourth Military Medical University",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Shiqiang Yu, MD,PhD",
                "OverallOfficialAffiliation":"Deparment of cardiovascular surgery, XiJing hospital, Fourth Military Medical University",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Deparment of Cardiovascular surgery,Xijing Hospital, Fourth Military Medical University",
                "LocationCity":"Xi'an",
                "LocationState":"Shaanxi",
                "LocationZip":"710032",
                "LocationCountry":"China"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"32151220",
                "ReferenceType":"derived",
                "ReferenceCitation":"Zhao K, Zhang Y, Li J, Cui Q, Zhao R, Chen W, Liu J, Zhao B, Wan Y, Ma XL, Yu S, Yi D, Gao F. Modified Glucose-Insulin-Potassium Regimen Provides Cardioprotection With Improved Tissue Perfusion in Patients Undergoing Cardiopulmonary Bypass Surgery. J Am Heart Assoc. 2020 Mar 17;9(6):e012376. doi: 10.1161/JAHA.119.012376. Epub 2020 Mar 10."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000007328",
                "InterventionMeshTerm":"Insulin"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000007004",
                "InterventionAncestorTerm":"Hypoglycemic Agents"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M20444",
                "InterventionBrowseLeafName":"Pharmaceutical Solutions",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M8948",
                "InterventionBrowseLeafName":"Insulin",
                "InterventionBrowseLeafAsFound":"Insulin",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M178017",
                "InterventionBrowseLeafName":"Insulin, Globin Zinc",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M8637",
                "InterventionBrowseLeafName":"Hypoglycemic Agents",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              },{
                "InterventionBrowseBranchAbbrev":"Hypo",
                "InterventionBrowseBranchName":"Hypoglycemic Agents"
              }
            ]
          }
        }
      }
    }
  }
}