Recent clinical severe decompensation of a presumed cirrhosis related to a precipitating event Digestive System Cirrhosis
Conditions
Interventions
Comparison of standard medical treatment (SMT) for acute-on-chronic liver failure versus MARS® liver support therapy in addition to SMT.
Sponsors
Gambro Lundia AB (Sweden)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent by patient or next of kin 2. Age greater than 18 years 3. 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) 4. 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: 4.1. Hepatorenal syndrome (impaired renal function with creatinine greater than 1.5 mg/dl or greater than 133 µmol/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) 4.2. Hepatic Encephalopathy greater than or equal to II° 4.3. 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 criteria
Exclusion criteria: 1. Progressive jaundice and deterioration as a natural course of a chronic liver disease without precipitating (trigger) event 2. Severe thrombocytopenia (platelet count less than or equal to 50 glutamic pyruvic transaminase [GPT]/l) 3. Severe coagulopathy (international normalised ratio [INR] greater than 2.3) 4. Need for renal replacement therapy within three days prior to enrolment 5. Severe infection without antibiotic treatment for at least 24 hours. Uncontrolled bacterial infection. 6. Active bleeding within 48 hours prior to enrolment 7. Proven hepatocellular carcinoma (HCC) greater than 4 cm or infiltration of portal vein or acute portal vein thrombosis 8. Severe cardiopulmonary disease (New York Heart Association [NYHA] greater than or equal to 2) 9. Pregnancy/lactation 10. Mean arterial pressure (MAP) less than 60 mmHg despite vasopressor agents (norepinephrine greater than 1 µg/kg/min) for blood pressure support 11. Overt clinical evidence for disseminated intravascular coagulation (DIC) 12. Clinical evidence for coma of non-hepatic origin 13. Extra-hepatic cholestasis 14. Severe intrinsic renal disease 15. Extended surgical procedure within the last four weeks or unsolved surgical problems 16. Known human immunodeficiency virus (HIV) infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day transplant-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 28-day survival regardless of transplantation 2. 84-day survival 3. In-hospital mortality 4. Time course of clinical state (number and severity of complications, vital signs, scoring systems, laboratory tests) 5. Economic analysis | — |
Countries
Austria, Belgium, Denmark, France, Germany, Italy, Spain, Switzerland, United Kingdom
Outcome results
None listed