Critical Illness, Liver Dysfunction
Conditions
Keywords
Liver failure, Hepatic insufficiency, Artificial liver, Albumin dialysis
Brief summary
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.
Interventions
DEVICEHepa Wash
Intervention frequency: 1-10 treatments (decision of the investigator) Duration of intervention per patient: Treatment until recovery or death (max. 6 weeks)
PROCEDUREStandard Medical Therapy
Standard of care treatment
Sponsors
Hepa Wash GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day mortality rate | 30 days | Mortality 30 days after the first intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 30 days | Adverse Events during the intervention will be assessed |
| Number of days on ventilation | 30 days | Number of days with need of mechanical ventilation after first intervention |
| Multiorgan system failure according to the Sequential Organ Failure Assessment (SOFA) Score | 72 hours | The Sequential Organ Failure Assessment (SOFA) Score analyses the severity of illness according to 6 organ systems (CNS, Liver, Kidney, Hemodynamic, Coagulation, Lung). Each system is given 0 to 4 points for a total of 24 points. A value \>2 in each of the systems indicates organ failure. An overall value \> 14 indicates 90% probability of in-hospital mortality. |
| 180d-mortality rate | 180 days | Mortality 180 days after the first intervention |
| 1y-mortality rate | 1 year | Mortality 1 year after the first intervention |
| Number of days without extracorporeal treatment | 30 days | Number of days without the need of extracorporeal renal and/or liver replacement therapy after the first intervention |
Countries
Germany
Outcome results
None listed