Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-02-26 @ 2:17 AM
Study NCT ID:
NCT01328132
Status:
UNKNOWN
Last Update Posted:
2011-04-04
First Post:
2011-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Hyperoncotic Albumin on Vascular Hemodynamics and Oxygen Delivery Following Orthotopic Liver Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000418', 'term': 'Albumins'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-03-31', 'studyFirstSubmitDate': '2011-03-31', 'studyFirstSubmitQcDate': '2011-03-31', 'lastUpdatePostDateStruct': {'date': '2011-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac index (CI)', 'timeFrame': '60 minutes after the infusion of the fluid'}], 'secondaryOutcomes': [{'measure': 'Cardiac function response', 'timeFrame': '30 and 60 minutes after the infusion of the fluid', 'description': 'An improvement in Q due primarily to a change in cardiac function should have an increase in Q of ≥ 0.3 ml/min/m2/mmHg'}, {'measure': 'A decrease in leak and plasma expansion', 'timeFrame': '30 and 60 minutes after the infusion of the fluid', 'description': 'A decrease in leak and plasma expansion will be determined by the Harrison formula for calculating a change in plasma volume from the change in Hb and change in Hct'}, {'measure': 'Cardiac output response', 'timeFrame': '30 and 60 minutes after the infusion of the fluid', 'description': 'Cardiac output response primarily due to a "volume effect" would be expected to have an increase of CVP of a minimum of 2 mmHg and an increase in CI of \\> 0.3 L/min/m2 per mmHg.'}, {'measure': 'Detoxification effect of albumin', 'timeFrame': '30 and 60 minutes after infusion', 'description': 'A increase in vascular tone will be identified by an increase in systemic vascular resistance or a rise in blood pressure without a change in cardiac output or a rise in blood pressure with a fall in cardiac output'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Liver', 'transplant', 'albumin'], 'conditions': ['Other Complications of Liver Transplant']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to assess the effect of hyperoncotic albumin on vascular hemodynamics and oxygen delivery after orthotopic liver transplant. The secondary aim is to try to identify the dominant physiological mechanism so that we will be able to better identify patients that may benefit from the use of albumin (25%) boluses in addition to standard care in patients following liver transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Patients from the Critical care Unit\n* Patients with a pulmonary artery occlusion catheter Inclusion:patients immediately following liver transplantation\n\nExclusion Criteria:\n\n* Patients not giving informed consent\n* Patients who have received \\> 300 ml of albumin within 24 hours prior to inclusion\n* Patients known to have previous adverse reaction to human albumin solution\n* Patients who have religious restriction to receive human blood products\n* Patient who have initial graft failure\n* Patients with fluctuating hemodynamics\n* Concerns of the treating surgeon'}, 'identificationModule': {'nctId': 'NCT01328132', 'briefTitle': 'Effect of Hyperoncotic Albumin on Vascular Hemodynamics and Oxygen Delivery Following Orthotopic Liver Transplant', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'orgStudyIdInfo': {'id': '10-287-BMA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Saline', 'interventionNames': ['Drug: Saline']}, {'type': 'EXPERIMENTAL', 'label': '25% albumin', 'interventionNames': ['Drug: 25% albumin']}], 'interventions': [{'name': 'Saline', 'type': 'DRUG', 'description': '100 ml of saline will be given in addition to the standard of care every 8 hours for 24 hours.', 'armGroupLabels': ['Saline']}, {'name': '25% albumin', 'type': 'DRUG', 'description': '100 ml of 25% albumin will be given in addition to the standard of care every 8 hours for 24 hours', 'armGroupLabels': ['25% albumin']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3A1A1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Royal Victoria Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Sheldon Magder, MD', 'role': 'CONTACT', 'email': 'sheldon.magder@muhc.mcgill.ca', 'phone': '514-934-1934', 'phoneExt': '35253'}, {'name': 'Thomas Lescot, MD, PhD', 'role': 'CONTACT', 'email': 'thomas.lescot@mail.mcgill.ca', 'phone': '514-934-1934', 'phoneExt': '36736'}], 'overallOfficials': [{'name': 'Sheldon Magder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Sheldon Magder, MD', 'oldOrganization': 'McGill University Health Center'}}}}