Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2026-01-01 @ 2:39 PM
Study NCT ID:
NCT00842803
Status:
UNKNOWN
Last Update Posted:
2009-09-18
First Post:
2009-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Operative Use of Salt Poor Albumin Solution in Resuscitation of Orthotopic Liver Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000418', 'term': 'Albumins'}], 'ancestors': [{'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-09-17', 'studyFirstSubmitDate': '2009-02-11', 'studyFirstSubmitQcDate': '2009-02-11', 'lastUpdatePostDateStruct': {'date': '2009-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post Transplant Liver Function Test (PTLFT)', 'timeFrame': 'Post-operative Day1 through 7 and Day 15,30, 45'}], 'secondaryOutcomes': [{'measure': 'Functional 6 minutes walking test', 'timeFrame': 'Post-operative'}, {'measure': 'Calculated creatinine clearance', 'timeFrame': 'Post-operative day 1, 7, 15, 30, 45'}, {'measure': 'Length of hospital stay', 'timeFrame': 'post-operative'}, {'measure': 'ICU length of stay', 'timeFrame': 'post-operative'}, {'measure': 'duration of mechanical ventilation', 'timeFrame': 'post-operative'}, {'measure': 'duration of renal replacement therapy', 'timeFrame': 'postoperative'}, {'measure': 'ICU readmission rate', 'timeFrame': 'post-operative'}, {'measure': 'reintubation rate', 'timeFrame': 'post-operative'}, {'measure': 'Post-operative infection rate', 'timeFrame': 'Post-operative'}, {'measure': 'Need to re-operation unrelated to technical complication', 'timeFrame': 'post-operative'}, {'measure': 'Functional hand grip Jamar Dynamometer hand grip test', 'timeFrame': 'Post-op day 7, 15, 30'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Liver', 'transplant', 'albumin', 'outcome', 'Liver transplant recipients canadian transplant status 1 or 2'], 'conditions': ['Liver Transplantation']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to examine if outcome after liver transplantation is improved by using albumin infusion post-transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Canadian Transplant status 1 or 2\n* Patients at the Royal Victoria Hospital, Montreal, Canada\n\nExclusion Criteria:\n\n* Emergency liver transplant (canadian transplant status 3 or 4)\n* patients who have received more than 300cc of albumin within 48 hours prior to transplant\n* patients who underwent previous solid organ transplant\n* multi-organs transplant recipients\n* patients who had previous adverse reaction to human albumin solution\n* patients who have religious restriction to receiving human blood products.\n* patients or surrogate unable to give consent to the study'}, 'identificationModule': {'nctId': 'NCT00842803', 'briefTitle': 'Post-Operative Use of Salt Poor Albumin Solution in Resuscitation of Orthotopic Liver Transplant', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'Post-Operative Use of Salt Poor Albumin Solution in Resuscitation of Orthotopic Liver Transplant Recipients Status 1-2. A Prospective Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'SDR-08-030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Patients in this group will not be allowed albumin or any other colloids fluid for the first 7 days post-operative'}, {'type': 'EXPERIMENTAL', 'label': 'Albumin group', 'description': 'Patients in this arm will receive albumin infusions 3 times a day for the first 7 days post-operative', 'interventionNames': ['Drug: Albumin infusion (25% albumin)']}], 'interventions': [{'name': 'Albumin infusion (25% albumin)', 'type': 'DRUG', 'description': 'Patients in this arm will receive albumin infusions 3 times a day for the first 7 days post-operative', 'armGroupLabels': ['Albumin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3A1A1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Royal Victoria Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Mathieu Rousseau, MD', 'role': 'CONTACT', 'email': 'mathieu.rousseau@mail.mcgill.ca', 'phone': '514.567.0292'}, {'name': 'Mazen Hassanain, MD', 'role': 'CONTACT', 'email': 'mazen.hassanain@muhc.mcgill.ca', 'phone': '514.934.1934', 'phoneExt': '31600'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr Peter Metrakos', 'oldOrganization': 'MUHC'}}}}