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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
59
10 treatments with the MARS system during the first three weeks after enrollment of 5-8 hours each.
Standard medical therapy for treatment of the liver disease according to local policy with recommendations as per protocol
Standard medical therapy for treatment of the liver disease according to local policy with recommendations as per protocol
AKH Wien
Vienna, Austria
Universitaire Ziekenhuitzen
Leuven, Belgium
Show improvement of transplant free survival under MARS in comparison to Standard Medical Treatment.
Time frame: 28 days
Survival regardless of transplantation
Time frame: 28 days
general survival
Time frame: 3 months
in-hospital mortality
Time frame: 3 months
time course of clinical state (number and severity of complications, vital signs, scoring systems, lab tests)
Time frame: 3 months
economic analysis (length of stay, ICU days, readmissions within observation period)
Time frame: 3 months
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Berlin, Germany
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Halle, Germany
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...and 9 more locations