NCT00614146

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

Therapeutic Impact of Albumin Dialysis With the Molecular Adsorbents Recirculating System (MARS®) in Severely Decompensated Chronic Liver Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Vantive Health LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Current medical therapy for end stage liver disease is focused on substitution of blood or plasma products, volume expansion or antibiotic treatment. The only specific treatment is liver transplantation, which is limited by available organs and may be a therapeutic option only for a very minority of patients with recently deteriorated end stage liver disease. The clinical management of defect hepatic synthesis and metabolic regulation has been improved dramatically within the past decades by the development of transfusion and intensive care medicine, but the replacement of detoxification has been more difficult, as the majority of endogenous toxins accumulating in liver failure is bound to albumin. Therefore, conventional dialysis and hemofiltration have been shown to be ineffective for their removal. The present study is based on the theory, that supporting the failing liver by the removal of toxic substances with a biocompatible method (the MARS system) may improve the capacity for recovery of the patient.

Conditions

• Liver Failure

Interventions

Type	Name	Description
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

Timeline

• Start date: 2003-04-01
• Primary completion: 2008-01-01
• Completion: 2009-04-01
• First posted: 2008-02-13
• Last updated: 2025-03-13

Locations

19 sites across 9 countries: Austria, Belgium, Denmark, France, Germany, Italy, Spain, Switzerland, United Kingdom