Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-25 @ 7:00 PM
Study NCT ID:
NCT00407004
Status:
COMPLETED
Last Update Posted:
2006-12-04
First Post:
2006-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Elimination of Albumin-Bound Substances by MARS and Prometheus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D065290', 'term': 'Acute-On-Chronic Liver Failure'}], 'ancestors': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D017114', 'term': 'Liver Failure, Acute'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-11', 'completionDateStruct': {'date': '2004-04'}, 'lastUpdateSubmitDate': '2006-12-01', 'studyFirstSubmitDate': '2006-12-01', 'studyFirstSubmitQcDate': '2006-12-01', 'lastUpdatePostDateStruct': {'date': '2006-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum levels of albumin-bound substances'}], 'secondaryOutcomes': [{'measure': 'plasma clearance of albumin-bound substances'}]}, 'conditionsModule': {'keywords': ['acute-on-chronic liver failure, MARS, Prometheus, bilirubin, bile acids, cytokines'], 'conditions': ['Liver Failure']}, 'referencesModule': {'references': [{'pmid': '16023249', 'type': 'RESULT', 'citation': 'Krisper P, Haditsch B, Stauber R, Jung A, Stadlbauer V, Trauner M, Holzer H, Schneditz D. In vivo quantification of liver dialysis: comparison of albumin dialysis and fractionated plasma separation. J Hepatol. 2005 Sep;43(3):451-7. doi: 10.1016/j.jhep.2005.02.038.'}, {'pmid': '16847391', 'type': 'RESULT', 'citation': 'Jung A, Krisper P, Haditsch B, Stauber RE, Trauner M, Holzer H, Schneditz D. Bilirubin kinetic modeling for quantification of extracorporeal liver support. Blood Purif. 2006;24(4):413-22. doi: 10.1159/000094575. Epub 2006 Jul 14.'}]}, 'descriptionModule': {'briefSummary': 'This trial compares the efficacy of two artificial liver support systems, MARS (Molecular Adsorbents Recirculating System) and Prometheus (FPSA, Fractionated Plasma Separation and Adsorption), in removing albumin-bound substances such as bilirubin, bile acids, and cytokines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* consecutive patients with acute-on-chronic liver failure (severe deterioration of chronic liver disease) unresponsive to standard medical treatment for \\>=48 hours\n\nExclusion Criteria:\n\n* arterial hypotension\n* extrahepatic malignancy'}, 'identificationModule': {'nctId': 'NCT00407004', 'briefTitle': 'Elimination of Albumin-Bound Substances by MARS and Prometheus', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Effect of Extracorporeal Liver Support by MARS and Prometheus on Albumin-Bound Substances in Acute-on-Chronic Liver Failure', 'orgStudyIdInfo': {'id': 'EAT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MARS (Molecular Adsorbents Recirculating System)', 'type': 'DEVICE'}, {'name': 'Prometheus (FPSA, Fractionated Plasma Separation and Adsorption)', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'overallOfficials': [{'name': 'Rudolf E. Stauber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz'}, {'name': 'Peter Krisper, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fresenius Medical Care North America', 'class': 'INDUSTRY'}]}}}