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Elimination of Albumin-Bound Substances by MARS and Prometheus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00407004
First Posted: December 4, 2006
Last Update Posted: December 4, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fresenius Medical Care North America
Information provided by:
Medical University of Graz
  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
Intervention Model: Crossover Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: December 1, 2006
First Posted: December 4, 2006
Last Update Posted: December 4, 2006
Last Verified: November 2006

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
Acute-On-Chronic Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Liver Failure, Acute