Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT01485432
Status:
TERMINATED
Last Update Posted:
2020-01-14
First Post:
2011-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Goal Directed Hemodynamic Management and Renal Outcome After Renal Transplant Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051799', 'term': 'Delayed Graft Function'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Low recruitment of patients.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-10', 'studyFirstSubmitDate': '2011-11-11', 'studyFirstSubmitQcDate': '2011-12-01', 'lastUpdatePostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'delayed graft function', 'timeFrame': 'Start of anesthesia until day 7 after the operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Renal transplant surgery', 'hemodynamic management', 'PiCCO', 'delayed graft function'], 'conditions': ['Renal Transplant Surgery']}, 'referencesModule': {'references': [{'pmid': '17119923', 'type': 'BACKGROUND', 'citation': 'Goepfert MS, Reuter DA, Akyol D, Lamm P, Kilger E, Goetz AE. Goal-directed fluid management reduces vasopressor and catecholamine use in cardiac surgery patients. Intensive Care Med. 2007 Jan;33(1):96-103. doi: 10.1007/s00134-006-0404-2. Epub 2006 Nov 21.'}, {'pmid': '10916111', 'type': 'BACKGROUND', 'citation': 'Boom H, Mallat MJ, de Fijter JW, Zwinderman AH, Paul LC. Delayed graft function influences renal function, but not survival. Kidney Int. 2000 Aug;58(2):859-66. doi: 10.1046/j.1523-1755.2000.00235.x.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to compare the incidence of delayed graft function in patients following renal transplant surgery with different perioperative hemodynamic managements: a goal directed hemodynamic management group (using PiCCO) and a control group.', 'detailedDescription': 'Volume assessment and management during renal transplantation is one of the most challenging problems the anesthetist has to deal with. It seems sensible that individualized volume management and hydration therapy during the operation and during the stay at the intensive care unit could improve perfusion of the transplanted organ resulting in a better transplant function. Aim of this study is to investigate the impact of a goal directed hemodynamic management on incidence of delayed graft function (DGF) after renal transplant surgery.\n\nTherefore patients will be randomized in one of two groups, the PiCCO group with goal directed hemodynamic management during operation and during the ICU-stay and the control group with hemodynamic management performed according to heart rate, blood pressure and central venous pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing renal transplant surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Renal Transplant Surgery\n* Age ≥ 65 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Contraindications for an arterial line in the femoral artery:\n\n * stents\n * bypasses\n * severe peripheral artery occlusive disease'}, 'identificationModule': {'nctId': 'NCT01485432', 'acronym': 'IROR', 'briefTitle': 'Goal Directed Hemodynamic Management and Renal Outcome After Renal Transplant Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Can Goal Directed Hemodynamic Management Improve Renal Outcome After Renal Transplant Surgery?', 'orgStudyIdInfo': {'id': 'IROR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'P group', 'description': 'Group P: Fluid Management according to measurements with PiCCO®', 'interventionNames': ['Device: PiCCO® Monitoring']}, {'label': 'C group', 'description': 'Group C: Conventional fluid management'}], 'interventions': [{'name': 'PiCCO® Monitoring', 'type': 'DEVICE', 'description': 'Fluid and vasopressor management according to PiCCO measurements', 'armGroupLabels': ['P group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Bettina Jungwirth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}