{
  "FullStudy":{
    "Rank":217655,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518569",
          "OrgStudyIdInfo":{
            "OrgStudyId":"KUH1160040"
          },
          "Organization":{
            "OrgFullName":"Konkuk University Medical Center",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Ulinastatin's Anti-inflammatory Reaction in Cardiac Surgery",
          "OfficialTitle":"Effect of Ulinastatin on Postoperative Systemic Inflammatory Response in Cardiac Surgery",
          "Acronym":"ulistin"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"March 2008"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2008",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"August 2008",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 20, 2012",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 25, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 26, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Tae-Yop Kim, MD PhD",
            "ResponsiblePartyInvestigatorTitle":"Professor of Anesthesiology",
            "ResponsiblePartyInvestigatorAffiliation":"Konkuk University Medical Center"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Konkuk University Medical Center",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of the present study is to determine whether ulinastatin, urinary anti-trypsin inhibitor, attenuates cardiopulmonary bypass (CPB)-activated systemic inflammatory response in cardiac surgery with CPB.\n\nSerial measurements and analysis of several inflammatory cytokines (bactericidal permeability increasing protein, interleukin-6, tumor necrosis factor-α)as well as markers of cardiac injury, renal impairment and oxygenation profile will be performed to determine ulinastatin's efficacy.",
          "DetailedDescription":"Applying aortic cross-clamp (ACC) and cardiopulmonary bypass (CPB) for cardiac surgery produces variable systemic inflammatory reactions. As a common complication of those reactions, pulmonary dysfunction, which usually indicated by postoperative hypoxemia, is frequently associated with cardiac surgery employing CPB and has been used as a major predictor of morbidity and mortality.\n\nCirculating humoral and cellular factors are involved in the development of the systemic inflammatory reactions including organ dysfunction. So far, many studies analyzed the concentration of inflammatory marker (cytokine) to determine the degree of systemic inflammatory responses in various conditions.\n\nUlinastatin has anti-inflammatory activity and suppresses the infiltration of neutrophils. Previous studies suggested ulinastatin's cytoprotective effect against ischemia-reperfusion injury in major organs and its inhibition of inflammatory marker production.\n\nThe purpose of the present study is to determine ulinastatin's possible protective efficacy of in attenuating CPB-activated systemic inflammatory response regarding postoperative cardiac, renal and pulmonary dysfunction in cardiac surgery with CPB. Serial measurements and analysis of several inflammatory cytokines, such as bactericidal permeability increasing protein (BPI), interleukin (IL)-6, tumor necrosis factor (TNF)-α, as well as markers of cardiac injury, renal impairment and oxygenation profile, such as creatine kinase-MB (CK-MB), troponin I (TnI), C-reactive protein (CRP), arterial O2 tension /inspired O2 fraction (PaO2/FiO2 ratio), will be performed to this purpose."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Cardiovascular Disease"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "ulinastatin",
              "systemic inflammation",
              "cardiac surgery",
              "cardiopulmonary bypass"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 4"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Prevention",
            "DesignMaskingInfo":{
              "DesignMasking":"Triple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider",
                  "Investigator"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"26",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"placebo",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"normal saline, same amount, iv",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: placebo"
                  ]
                }
              },{
                "ArmGroupLabel":"ulinastatin",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"5000 unit/kg iv",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: ulinastatin"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"ulinastatin",
                "InterventionDescription":"ulinastatin 5000 unit/kg iv before the initiation of CPB",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "ulinastatin"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "ulistin"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"placebo",
                "InterventionDescription":"placebo (the same amount of normal saline) iv before the initiation of CPB",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "placebo"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "normall saline"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"bactericidal permeability increasing protein",
                "PrimaryOutcomeTimeFrame":"5-30 min before the end of anesthesia"
              },{
                "PrimaryOutcomeMeasure":"interleukin-6",
                "PrimaryOutcomeTimeFrame":"5-30 min before the end of anesthesia"
              },{
                "PrimaryOutcomeMeasure":"tumor necrosis factorTNF-α",
                "PrimaryOutcomeTimeFrame":"5-30 min before the end of anesthesia"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Creatine kinase-MB",
                "SecondaryOutcomeTimeFrame":"before anesthesia, 24 hour after the end of anesthesia"
              },{
                "SecondaryOutcomeMeasure":"troponin I",
                "SecondaryOutcomeTimeFrame":"before anesthesia, 24 hour after the end of anesthesia"
              },{
                "SecondaryOutcomeMeasure":"C-reactive protein",
                "SecondaryOutcomeTimeFrame":"before anesthesia, 24 hour after the end of anesthesia"
              },{
                "SecondaryOutcomeMeasure":"serum creatinine",
                "SecondaryOutcomeTimeFrame":"before anesthesia, 24 hour after the end of anesthesia"
              },{
                "SecondaryOutcomeMeasure":"PaO2/FiO2 ratio",
                "SecondaryOutcomeTimeFrame":"before anesthesia, 24 hour after the end of anesthesia"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nelective cardiac surgery employing CPB\n\nExclusion Criteria:\n\nurgent/emergency surgery,\nprevious heart surgery,\ncombined CABG and valve surgery,\nage > 75 yrs,\nleft ventricular ejection fraction < 0.45,\ndiabetes treated with insulin,\nactive gastropathic disorder,\ntreatment for chronic obstructive pulmonary disease,\npreoperative use of steroids\npostoperative re-operation due to bleeding control\npre and postoperative renal replacement therapy\nleft ventricular assist device implantation",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"25 Years",
          "MaximumAge":"75 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Konkuk University Medical Center",
                "LocationCity":"Seoul",
                "LocationZip":"143-729",
                "LocationCountry":"Korea, Republic of"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"16540949",
                "ReferenceType":"background",
                "ReferenceCitation":"Nakanishi K, Takeda S, Sakamoto A, Kitamura A. Effects of ulinastatin treatment on the cardiopulmonary bypass-induced hemodynamic instability and pulmonary dysfunction. Crit Care Med. 2006 May;34(5):1351-7."
              },{
                "ReferencePMID":"9583572",
                "ReferenceType":"background",
                "ReferenceCitation":"Hill GE. Cardiopulmonary bypass-induced inflammation: is it important? J Cardiothorac Vasc Anesth. 1998 Apr;12(2 Suppl 1):21-5. Review."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"C000028665",
                "InterventionMeshTerm":"Urinastatin"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000014361",
                "InterventionAncestorTerm":"Trypsin Inhibitors"
              },{
                "InterventionAncestorId":"D000015842",
                "InterventionAncestorTerm":"Serine Proteinase Inhibitors"
              },{
                "InterventionAncestorId":"D000011480",
                "InterventionAncestorTerm":"Protease Inhibitors"
              },{
                "InterventionAncestorId":"D000004791",
                "InterventionAncestorTerm":"Enzyme Inhibitors"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M248162",
                "InterventionBrowseLeafName":"Urinastatin",
                "InterventionBrowseLeafAsFound":"Ulinastatin",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M15695",
                "InterventionBrowseLeafName":"Trypsin Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M12926",
                "InterventionBrowseLeafName":"Protease Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M16974",
                "InterventionBrowseLeafName":"Serine Proteinase Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M18192",
                "InterventionBrowseLeafName":"HIV Protease Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"T18",
                "InterventionBrowseLeafName":"Serine",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              },{
                "InterventionBrowseBranchAbbrev":"Infe",
                "InterventionBrowseBranchName":"Anti-Infective Agents"
              },{
                "InterventionBrowseBranchAbbrev":"AA",
                "InterventionBrowseBranchName":"Amino Acids"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000002318",
                "ConditionMeshTerm":"Cardiovascular Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M8876",
                "ConditionBrowseLeafName":"Inflammation",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}