Elimination of Albumin-Bound Substances by MARS and Prometheus

Liver Failure Clinical Trial

Official title:

Effect of Extracorporeal Liver Support by MARS and Prometheus on Albumin-Bound Substances in Acute-on-Chronic Liver Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00407004
• Other study ID #: EAT
• Status: Completed
• Phase: N/A
• First received: December 1, 2006
• Last updated: December 1, 2006
• Start date: March 2003
• Est. completion date: April 2004

Study information

• Verified date: November 2006
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Liver Disease
• Liver Failure

Intervention

Device:
• MARS (Molecular Adsorbents Recirculating System)

• Prometheus (FPSA, Fractionated Plasma Separation and Adsorption)

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	Fresenius Medical Care North America

Country where clinical trial is conducted

Austria, 

References & Publications (2)

Jung A, Krisper P, Haditsch B, Stauber RE, Trauner M, Holzer H, Schneditz D. Bilirubin kinetic modeling for quantification of extracorporeal liver support. Blood Purif. 2006;24(4):413-22. Epub 2006 Jul 14. — View Citation

Krisper P, Haditsch B, Stauber R, Jung A, Stadlbauer V, Trauner M, Holzer H, Schneditz D. In vivo quantification of liver dialysis: comparison of albumin dialysis and fractionated plasma separation. J Hepatol. 2005 Sep;43(3):451-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum levels of albumin-bound substances
Secondary	plasma clearance of albumin-bound substances