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Elimination of Albumin-Bound Substances by MARS and Prometheus

This study has been completed.
Sponsor:
Collaborator:
Fresenius Medical Care North America
Information provided by:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00407004
First received: December 1, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  Purpose

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.


Condition Intervention
Liver Failure
 Device: MARS (Molecular Adsorbents Recirculating System)
Device: Prometheus (FPSA, Fractionated Plasma Separation and Adsorption)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Extracorporeal Liver Support by MARS and Prometheus on Albumin-Bound Substances in Acute-on-Chronic Liver Failure

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • serum levels of albumin-bound substances

Secondary Outcome Measures:
  • plasma clearance of albumin-bound substances

Estimated Enrollment: 10
Study Start Date: March 2003
Estimated Study Completion Date: April 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • consecutive patients with acute-on-chronic liver failure (severe deterioration of chronic liver disease) unresponsive to standard medical treatment for >=48 hours

Exclusion Criteria:

  • arterial hypotension
  • extrahepatic malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00407004

Locations
Austria
Medical University of Graz
Graz, Austria, A-8036
Sponsors and Collaborators
Medical University of Graz
Fresenius Medical Care North America
Investigators
Principal Investigator: Rudolf E. Stauber, MD Medical University of Graz
Principal Investigator: Peter Krisper, MD Medical University of Graz
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00407004     History of Changes
Other Study ID Numbers: EAT
Study First Received: December 1, 2006
Last Updated: December 1, 2006
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Graz:
acute-on-chronic liver failure, MARS, Prometheus, bilirubin, bile acids, cytokines

Additional relevant MeSH terms:
Liver Failure
End Stage Liver Disease
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 18, 2013