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Elimination of Albumin-Bound Substances by MARS and Prometheus

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. Identifier: NCT00407004
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : December 4, 2006
Fresenius Medical Care North America
Information provided by:
Medical University of Graz

Brief Summary:
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 or disease Intervention/treatment Phase
Liver Failure Device: MARS (Molecular Adsorbents Recirculating System) Device: Prometheus (FPSA, Fractionated Plasma Separation and Adsorption) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
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
Study Start Date : March 2003
Study Completion Date : April 2004

Primary Outcome Measures :
  1. serum levels of albumin-bound substances

Secondary Outcome Measures :
  1. plasma clearance of albumin-bound substances

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00407004

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Medical University of Graz
Graz, Austria, A-8036
Sponsors and Collaborators
Medical University of Graz
Fresenius Medical Care North America
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Principal Investigator: Rudolf E. Stauber, MD Medical University of Graz
Principal Investigator: Peter Krisper, MD Medical University of Graz
Publications of Results:
Layout table for additonal information Identifier: NCT00407004    
Other Study ID Numbers: EAT
First Posted: December 4, 2006    Key Record Dates
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:
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Liver Failure
Hepatic Insufficiency
Acute-On-Chronic Liver Failure
Liver Diseases
Digestive System Diseases
Liver Failure, Acute