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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014