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Recompensation of Exacerbated Liver Insufficiency With Hyperbilirubinemia and/or Encephalopathy and/or Renal Failure

NCT00614146 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2025-03-13

No results posted yet for this study

Summary

The objective of this trial is to evaluate the impact of elimination of albumin bound substances during albumin dialysis (MARS®) on mortality and the clinical time course in patients with a recent severe clinical deterioration of chronic liver disease caused by a precipitating (trigger) event within 4 weeks manifested by jaundice, encephalopathy and/or renal failure.

Conditions

  • Liver Failure

Interventions

DEVICE

MARS device

10 treatments with the MARS system during the first three weeks after enrollment of 5-8 hours each.

PROCEDURE

Standard medical therapy

Standard medical therapy for treatment of the liver disease according to local policy with recommendations as per protocol

PROCEDURE

Standard medical therapy

Standard medical therapy for treatment of the liver disease according to local policy with recommendations as per protocol

Sponsors & Collaborators

  • 2ConduCT

    collaborator INDUSTRY

  • G.E.M. mbh Meerbusch

    collaborator OTHER

  • DatInf

    collaborator UNKNOWN

  • Gambro Lundia AB

    collaborator INDUSTRY

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Vantive Health LLC

    lead INDUSTRY

Principal Investigators

  • Rafael Banarès, Dr · Hospital Gregorio Maranon, Madrid

  • Vicente Arroyo, Pf · Clínic Barcelona, Hospital Universitari Villarroel

  • Roger Williams, Pf · Royal Free and University College Medical School, University College London

  • Steffen Mitzner, Dr · Dept. of Internal Medicine, University of Rostock

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2008-01-31
Completion
2009-04-30

Countries

  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Italy
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00614146 on ClinicalTrials.gov