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Elimination of Albumin-Bound Substances by MARS and Prometheus

NCT ID: NCT00407004

Last Updated: 2006-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2004-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Failure

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MARS (Molecular Adsorbents Recirculating System)

Intervention Type DEVICE

Prometheus (FPSA, Fractionated Plasma Separation and Adsorption)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fresenius Medical Care North America

INDUSTRY

Sponsor Role collaborator

Medical University of Graz

OTHER

Sponsor Role lead

Principal Investigators

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Rudolf E. Stauber, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Peter Krisper, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

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Medical University of Graz

Graz, , Austria

Site Status

Countries

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Austria

References

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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.

Reference Type RESULT
PMID: 16023249 (View on PubMed)

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.

Reference Type RESULT
PMID: 16847391 (View on PubMed)

Other Identifiers

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EAT

Identifier Type: -

Identifier Source: org_study_id