Status:
COMPLETED
Recompensation of Exacerbated Liver Insufficiency With Hyperbilirubinemia and/or Encephalopathy and/or Renal Failure
Lead Sponsor:
Vantive Health LLC
Collaborating Sponsors:
2ConduCT
G.E.M. mbh Meerbusch
Conditions:
Liver Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 sev...
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 transplantati...
Eligibility Criteria
Inclusion
- Signed written informed consent by patient or next of kin
- Age greater than 18 years
- Patients with a recent clinical severe decompensation of a presumed cirrhosis (based on clinical evaluation or radiological imaging) related to a precipitating (trigger) event (e.g. infection, bleeding, alcohol abuse)
- Intrahepatic cholestasis (bilirubin greater than 5 mg/dl or greater than 85 µmol/l, respectively) without evidence of extrahepatic origin
- and at least one of the following three:
- Hepatorenal syndrome (impaired renal function with creatinine greater than 1.5 mg/dl or greater than 133µmol/l without evidence of reduced vascular volume \[e.g. central venous pressure {CVP} greater than 8 cm H2O\] and no evidence of pre-existing renal failure)
- Hepatic Encephalopathy greater than or equal to II°
- Progressive Hyperbilirubinaemia: defined as a more than 50% increase of bilirubin before enrolment, whether in referral or currently in hospital up to a level of greater than 20 mg/dl (or greater than 340 µmol/l)
Exclusion
- Progressive jaundice and deterioration as a natural course of a chronic liver disease without precipitating (trigger) event
- Severe thrombocytopenia (platelet count less than or equal to 50 Glutamic Pyruvic Transaminase \[GPT\]/l)
- Severe coagulopathy (International Normalised Ratio \[INR\] greater than 2.3)
- Need for renal replacement therapy within three days prior to enrolment
- Severe infection without antibiotic treatment for at least 24 hours. Uncontrolled bacterial infection
- Active bleeding within 48 hours prior to enrolment
- Proven hepatocellular carcinoma (HCC) greater than 4 cm or infiltration of portal vein or acute portal vein thrombosis
- Severe cardiopulmonary disease (New York Heart Association \[NYHA\] greater than or equal to 2)
- Pregnancy/lactation
- Mean arterial pressure (MAP) less than 60 mmHg despite vasopressor agents (norepinephrine greater than 1 µg/kg/min) for blood pressure support
- Overt clinical evidence for Disseminated Intravascular Coagulation (DIC)
- Clinical evidence for coma of non-hepatic origin
- Extra-hepatic cholestasis
- Severe intrinsic renal disease
- Extended surgical procedure within the last four weeks or unsolved surgical problems
- Known human immunodeficiency virus (HIV) infection
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00614146
Start Date
April 1 2003
End Date
April 1 2009
Last Update
March 13 2025
Active Locations (19)
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1
AKH Wien
Vienna, Austria, 1090
2
Universitaire Ziekenhuitzen
Leuven, Belgium, 3000
3
Rigshospitalet Copenhagen
Copenhagen, Denmark, 2100
4
Hôpital Huriez
Lille, France, 59037