• Multiorgan system failure [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
• Safety (surrogate parameters) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
• Number of days on ventilation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
• Number of days without extracorporeal treatment [ Time Frame: 30 days ] [ Designated as safety issue: No ]
• 180d-mortality rate [ Time Frame: 180 days ] [ Designated as safety issue: No ]
• 1y-mortality rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Patients with compensated chronic liver disease who have an episode of acute deterioration of liver function (acute-on-chronic liver failure) are known to have up to 90% mortality rate. Hepa Wash(R) is a newly developed liver and renal support system that is based on the use of recycled albumin dialysate. The new system has shown a high detoxification capacity in in-vitro and preclinical studies. The aim of the study is to evaluate the safety and efficacy of the Hepa Wash system in patients with acute-on-chronic liver failure in the intensive care unit.

• Device: Hepa Wash

  Intervention frequency: 1-10 treatments (decision of the investigator)

  Duration of intervention per patient: Treatment until recovery or death (max. 6 weeks)

  Other Names:

  • Hepa Wash procedure
  • the HIP1001 system
• Procedure: Standard Medical Therapy
  Standard of care treatment

• Active Comparator: Control
  Standard Medical Therapy
  Intervention: Procedure: Standard Medical Therapy
• Experimental: Hepa Wash
  Treatment with the liver support system "Hepa Wash"
  Intervention: Device: Hepa Wash

Inclusion Criteria:

1. Patients with documented clinical or histological evidence of cirrhosis AND
2. Acute decompensation in previously stable cirrhotic liver disease AND
3. Bilirubin ≥ 2 mg/dl AND
4. SOFA ≥ 9 calculated after 12 hours of optimal medical therapy AND
5. Patient is in the intensive care unit AND
6. Informed consent of the patient or the legal representative AND
7. Patients are 18y or older AND
8. Enrollment of patients within 96 hours of fulfilling inclusion criteria (1-5)

Exclusion Criteria:

1. Untreatable extrahepatic cholestasis
2. Patient has a survival prognosis of less than 6 weeks because of a chronic disease (e.g. metastasizing cancer) and before the acute event which lead to the ICU admission.
3. PaO2/FIO2 ≤ 100 mmHg (respiratory SOFA-score of 4)
4. Patients who receive a vasopressor support of Dopamine >15 µg/kg/min or epinephrine >0.1 µg/kg/min or norepinephrine >0.1 µg/kg/min (cardiovascular SOFA-score of 4)
5. Patients with creatinine ≥5 mg/dl or urine output <200 ml/day (renal SOFA-score of 4)
6. Patients on kidney dialysis
7. Patient with MELD-score of 40
8. Mean arterial pressure ≤ 50 mmHg despite conventional medical treatment
9. Patient testament excludes the use of life-prolonging measures
10. Post-operative patients whose liver failure is related to liver surgery
11. Uncontrolled seizures
12. Active or uncontrolled bleeding
13. Weight ≥ 120 kg
14. Pregnancy
15. Patient diagnosed with Creutzfeldt-Jakob disease
16. Participation in another clinical study