• 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 hepatic dysfunction are known to have a high 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 hepatic dysfunction 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. Bilirubin ≥ 2 mg/dl AND
2. SOFA-score ≥ 9 calculated 12 hours after initiating medical resuscitation measures AND
3. Patient is in the intensive care unit AND
4. Signed informed consent of the patient or legal representative AND
5. Patients are 18 years or older AND
6. Enrollment of patients within 96 hours of fulfilling inclusion criteria (1-3).

Exclusion Criteria:

1. Patient with known history of chronic liver disease
2. Untreatable extrahepatic cholestasis
3. 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.
4. PaO2/FIO2 ≤ 100 mmHg
5. Patients on kidney dialysis
6. Patients with MELD-score of 40
7. Mean arterial pressure ≤ 50 mmHg despite conventional medical treatment
8. Patient testament excludes the use of life-prolonging measures
9. Post-operative patients whose liver failure is related to liver surgery
10. Uncontrolled seizures
11. Active or uncontrolled bleeding
12. Weight ≥ 120 kg
13. Pregnancy
14. Patient diagnosed with Creutzfeldt-Jakob disease
15. Participation in another clinical study