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Elimination of Albumin-Bound Substances by MARS and Prometheus

Primary Purpose

Liver Failure

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

MARS (Molecular Adsorbents Recirculating System)

Prometheus (FPSA, Fractionated Plasma Separation and Adsorption)

About this trial

This is an interventional treatment trial for Liver Failure focused on measuring acute-on-chronic liver failure, MARS, Prometheus, bilirubin, bile acids, cytokines

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical University of Graz

Outcomes

Primary Outcome Measures

serum levels of albumin-bound substances

Secondary Outcome Measures

plasma clearance of albumin-bound substances

Full Information

NCT ID

NCT00407004

First Posted

December 1, 2006

Last Updated

December 1, 2006

Sponsor

Medical University of Graz

Collaborators

Fresenius Medical Care North America

1. Study Identification

Unique Protocol Identification Number

NCT00407004

Brief Title

Elimination of Albumin-Bound Substances by MARS and Prometheus

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2006

Overall Recruitment Status

Completed

Study Start Date

March 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University of Graz

Collaborators

Fresenius Medical Care North America

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Failure

Keywords

acute-on-chronic liver failure, MARS, Prometheus, bilirubin, bile acids, cytokines

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

10 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

MARS (Molecular Adsorbents Recirculating System)

Intervention Type

Device

Intervention Name(s)

Prometheus (FPSA, Fractionated Plasma Separation and Adsorption)

Primary Outcome Measure Information:

Title

serum levels of albumin-bound substances

Secondary Outcome Measure Information:

Title

plasma clearance of albumin-bound substances

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rudolf E. Stauber, MD

Organizational Affiliation

Medical University of Graz

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Peter Krisper, MD

Organizational Affiliation

Medical University of Graz

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of Graz

City

Graz

ZIP/Postal Code

A-8036

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

16023249

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. doi: 10.1016/j.jhep.2005.02.038.

Results Reference

result

PubMed Identifier

16847391

Citation

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. doi: 10.1159/000094575. Epub 2006 Jul 14.

Results Reference

result

Learn more about this trial

Elimination of Albumin-Bound Substances by MARS and Prometheus

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