Ignite Creation Date:
2025-12-24 @ 5:15 PM
Ignite Modification Date:
2025-12-28 @ 6:33 PM
Study NCT ID:
NCT02079350
Status:
COMPLETED
Last Update Posted:
2014-03-05
First Post:
2014-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of %6 HES 130/0.4 and %4 Gelofusine Infusion on Kidney Function in the Living-donor Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-01', 'studyFirstSubmitDate': '2014-03-01', 'studyFirstSubmitQcDate': '2014-03-01', 'lastUpdatePostDateStruct': {'date': '2014-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'renal dysfunction', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'mortality', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Patients Undergoing Liver Transplantation']}, 'descriptionModule': {'briefSummary': 'Although the negative impacts of colloid solutions with high molecular weight on renal functions, combination of lower molecular weight colloid varieties with crystalloid solutions and its use during intraoperative period have been subject to current research. Since the first liver transplantation, pre-or post-transplantation renal problems are still among the main causes of mortality and morbidity. The aim of the study was to evaluate the effects of fluid replacement solutions used intraoperatively on renal functions in elective living-donor liver transplantation.This study was approved by the Ethics Committee of Hospital and all patients were informed and gave written consent. Participants were patients scheduled for elective living-donor liver transplantation. Patients with normal renal function were randomly allocated to infusion with 6% HES 130/0.4 (HES Group) and 4% Gelofusine (GEL Group). Blood samples were obtained before induction of anesthesia (baseline), at the end of the operation, and postoperative days 1 and 4. Different eGFR formulas using creatinine (MDRD, CKD-EPI, and Cockraud Gault) were used to calculate estimated glomerular filtration rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing living donor liver transplantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Normal kidney function\n\nExclusion Criteria:\n\n* anormal kidney function\n* cadaveric transplantation\n* emergency operation\n* patients less than 18 years old'}, 'identificationModule': {'nctId': 'NCT02079350', 'briefTitle': 'Impact of %6 HES 130/0.4 and %4 Gelofusine Infusion on Kidney Function in the Living-donor Liver Transplantation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turkiye Yuksek Ihtisas Education and Research Hospital'}, 'orgStudyIdInfo': {'id': '11739'}}, 'armsInterventionsModule': {'armGroups': [{'label': '%4 Gelofusine', 'description': 'patients administered %4 Gelofusine during liver transplantation', 'interventionNames': ['Drug: %6 HES and %4 Gelofusine']}, {'label': '%6 HES', 'description': 'patients administered %6 HES during liver transplantation', 'interventionNames': ['Drug: %6 HES and %4 Gelofusine']}], 'interventions': [{'name': '%6 HES and %4 Gelofusine', 'type': 'DRUG', 'armGroupLabels': ['%4 Gelofusine', '%6 HES']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06550', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Turkey Yuksek Ihtisas Education and Research Hospital, Anesthesiology Clinic', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turkiye Yuksek Ihtisas Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated professor', 'investigatorFullName': 'aslı demir', 'investigatorAffiliation': 'Turkiye Yuksek Ihtisas Education and Research Hospital'}}}}