{
  "FullStudy":{
    "Rank":217898,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515397",
          "OrgStudyIdInfo":{
            "OrgStudyId":"HC-G-H-0904"
          },
          "Organization":{
            "OrgFullName":"B. Braun Melsungen AG",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Comparison of Two Gelatine Solutions",
          "OfficialTitle":"Efficacy and Safety of a Balanced Gelatine Solution in Combination With a Balanced Electrolyte Solution Versus a Standard Gelatine Solution in Combination With a Non-balanced Electrolyte Solution in Patients Scheduled for Abdominal Surgery"
        },
        "StatusModule":{
          "StatusVerifiedDate":"November 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"December 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"January 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"January 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 2, 2012",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"November 26, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"November 27, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"B. Braun Melsungen AG",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The aim of volume replacement is to compensate a reduction in the intravascular volume e.g. during surgery and to counteract hypovolemia in order to maintain hemodynamics and vital functions. To achieve this, different plasma substitutes are available: Albumin, dextran, hydroxyethylstarches and gelatine. The aim of this study is to demonstrate that acid-base alterations during elective abdominal surgery can be reduced by the use of a new gelatine solution."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Hypovolemia"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Quadruple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"40",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"balanced gelatine solution",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"isotonic colloidal volume substitute",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Gelofusine balanced"
                  ]
                }
              },{
                "ArmGroupLabel":"non-balanced gelatine solution",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"colloidal volume substitute",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Gelofusine 4%"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Gelofusine balanced",
                "InterventionDescription":"Gelofusine balanced combined with Sterofundin ISO",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "balanced gelatine solution"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Gelofusine 4%",
                "InterventionDescription":"Gelofusine 4% combined with NaCl 0.9%",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "non-balanced gelatine solution"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"base excess [mmol/l]",
                "PrimaryOutcomeTimeFrame":"Change from baseline at end of surgery, an expected average of 2 hours surgery"
              },{
                "PrimaryOutcomeMeasure":"chloride [mmol/l]",
                "PrimaryOutcomeTimeFrame":"Change from baseline at end of surgery, an expected average of 2 hours surgery"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"arterial blood gase analyses",
                "SecondaryOutcomeTimeFrame":"until 12 hours after surgery"
              },{
                "SecondaryOutcomeMeasure":"coagulation status",
                "SecondaryOutcomeTimeFrame":"until 12 hours after surgery"
              },{
                "SecondaryOutcomeMeasure":"renal function",
                "SecondaryOutcomeTimeFrame":"until 12 hours after surgery"
              },{
                "SecondaryOutcomeMeasure":"adverse events",
                "SecondaryOutcomeTimeFrame":"until 12 hours after surgery"
              },{
                "SecondaryOutcomeMeasure":"hemodynamics (systolic and diastolic blood pressure)",
                "SecondaryOutcomeTimeFrame":"until 12 hours after surgery"
              },{
                "SecondaryOutcomeMeasure":"time on ventilation",
                "SecondaryOutcomeTimeFrame":"until 12 hours after surgery"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion:\n\nMale or female patients >= 18 years of age and <= 90 years of age. Women of child bearing potential must test negative on standard pregnancy test.\nPatients scheduled to undergo elective abdominal surgery (e.g. Rectal resection, liver resection, open bowl resection, duodenopancreatectomy reconstitution).\nScheduled intraoperative volume requirement of at least 15 ml / kg body weight (BROCA) gelatine solution\nProvision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations.\n\nExclusion:\n\nPatients of ASA-class > III\nKnown hypersensitivity to gelatine or to any of the constituents of the solution\nPatients treated with other colloid solutions and / or blood products 24 hours prior to surgery\nPatients on hemodialysis\nPatients suffering from decompensated renal function (i.e. serum creatinine > 3.0 mg/dl)\nPatients suffering from Hypervolemia Hyperhydration Severe blood coagulation disorders Hypernatremia (serum(Na+) > 150 mmol/L) Hyperchloremia (serum(Cl-) > 110 mmol/L)\nEstimated perioperative need for blood products of 3,5 ml / kg body weight (BROCA)\nLactation period\nSimultaneous participation in another clinical trial\nEmergencies",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"90 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Gernot Marx, Prof. Dr. med.",
                "OverallOfficialAffiliation":"Universitätsklinikum Aachen,Klinik für Operative Intensivmedizin",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Universitätsklinikum Aachen, Klinik für Anästhesiologie",
                "LocationCity":"Aachen",
                "LocationZip":"52074",
                "LocationCountry":"Germany"
              },{
                "LocationFacility":"Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Frankfurt/Main",
                "LocationCity":"Frankfurt/Main",
                "LocationZip":"60590",
                "LocationCountry":"Germany"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"31034525",
                "ReferenceType":"derived",
                "ReferenceCitation":"Marx G, Meybohm P, Schuerholz T, Lotz G, Ledinko M, Schindler AW, Rossaint R, Zacharowski K. Impact of a new balanced gelatine on electrolytes and pH in the perioperative care. PLoS One. 2019 Apr 29;14(4):e0213057. doi: 10.1371/journal.pone.0213057. eCollection 2019."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000011097",
                "InterventionMeshTerm":"Polygeline"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000010952",
                "InterventionAncestorTerm":"Plasma Substitutes"
              },{
                "InterventionAncestorId":"D000001802",
                "InterventionAncestorTerm":"Blood Substitutes"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M12565",
                "InterventionBrowseLeafName":"Polygeline",
                "InterventionBrowseLeafAsFound":"Gelofusine",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M12425",
                "InterventionBrowseLeafName":"Plasma Substitutes",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M3665",
                "InterventionBrowseLeafName":"Blood Substitutes",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"BlSubst",
                "InterventionBrowseBranchName":"Blood Substitutes"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000020896",
                "ConditionMeshTerm":"Hypovolemia"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M21218",
                "ConditionBrowseLeafName":"Hypovolemia",
                "ConditionBrowseLeafAsFound":"Hypovolemia",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}