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Elimination of Albumin-Bound Substances by MARS and Prometheus

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

Study Description
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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

Study Design
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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
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. serum levels of albumin-bound substances

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

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

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ClinicalTrials.gov 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