{
  "FullStudy":{
    "Rank":217824,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01516359",
          "OrgStudyIdInfo":{
            "OrgStudyId":"intestinal injury"
          },
          "Organization":{
            "OrgFullName":"First Affiliated Hospital, Sun Yat-Sen University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Incidence and Predictive Factors of Intestinal Injury in Patients Undergoing Heart Valve Replacements",
          "OfficialTitle":"Official Title is Required by the WHO and ICMJE"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"October 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"October 2012",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"November 2012",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 16, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 19, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 24, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor-Investigator",
            "ResponsiblePartyInvestigatorFullName":"Cai Li",
            "ResponsiblePartyInvestigatorTitle":"Vice head of Dept. of Anesthesiology",
            "ResponsiblePartyInvestigatorAffiliation":"First Affiliated Hospital, Sun Yat-Sen University"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Cai Li",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to investigate the incidence and predictive factors related to intestinal injury in patients undergoing heart valve replacement through a multicenter study in China.",
          "DetailedDescription":"Intestinal injury is one of main reasons for mobidity and mortality after heart valve replacement, but its incidence and potential risk factors remain unclear. A multicenter study in China is undertaken to investigate the incidence and predictive factors related to intestinal injury in patients undergoing heart valve replacement."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Injury of Other and Multiple Parts of Small Intestine"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "BioSpec":{
            "BioSpecRetention":"Samples With DNA",
            "BioSpecDescription":"Blood samples are retained for the detections of some biomarkers and gene polymorphism."
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"1000",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"patients with cardiac surgery"
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"score of gut dysfunction",
                "PrimaryOutcomeDescription":"At different time points, gut dysfunction is graded according to previous criterion.",
                "PrimaryOutcomeTimeFrame":"eight months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"The duration of cardiopulmonary bypass",
                "SecondaryOutcomeDescription":"Record the duration of cardiopulmonary bypass",
                "SecondaryOutcomeTimeFrame":"Eight months"
              },{
                "SecondaryOutcomeMeasure":"The duration for aortic artery clamping",
                "SecondaryOutcomeTimeFrame":"eight months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPatients undergoing heart valve replacements under cardiopulmonary bypass\n\nExclusion Criteria:\n\nPatients who die during or after operation",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"16 Years",
          "MaximumAge":"80 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"Patients undergoing heart valve replacements under cardiopulmonary bypass",
          "SamplingMethod":"Probability Sample"
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"Ke Xuan Liu, MD,Ph.D.",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"86-20-87755766",
                "CentralContactPhoneExt":"8273",
                "CentralContactEMail":"liukexuan807@yahoo.com.cn"
              }
            ]
          },
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Ke Xuan Liu, MD, Ph.D",
                "OverallOfficialAffiliation":"First Affiliated Hospital, Sun Yat-Sen University",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University",
                "LocationStatus":"Recruiting",
                "LocationCity":"Guangzhou",
                "LocationState":"Guangdong",
                "LocationZip":"510080",
                "LocationCountry":"China",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Ke Xuan Liu, MD, Ph.D.",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"86-13710684096",
                      "LocationContactEMail":"liukexuan807@yahoo.com.cn"
                    },{
                      "LocationContactName":"Cai Li, MD",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"86-18602017796",
                      "LocationContactEMail":"licaigz@yahoo.com.cn"
                    },{
                      "LocationContactName":"Ke Xuan Liu, MD, Ph.D.",
                      "LocationContactRole":"Principal Investigator"
                    }
                  ]
                }
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000014947",
                "ConditionMeshTerm":"Wounds and Injuries"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M16268",
                "ConditionBrowseLeafName":"Wounds and Injuries",
                "ConditionBrowseLeafAsFound":"Injury",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}