Acute on Chronic Hepatic Failure
Conditions
Keywords
Liver failure, Hepatic insufficiency, Liver Cirrhosis, Artificial liver, Albumin dialysis
Brief summary
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.
Interventions
DEVICEADVOS (Hepa 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
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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 |
|---|---|---|
| Safety (adverse events and surrogate parameters) | 30 days | Adverse Events during the intervention will be assessed. Additionally, liver parameters (e.g. Bilirubin), Kidney Parameters (e.g. Creatinin, Urea) and blood gas analysis will be performed. |
| Number of days on ventilation | 30 days | Number of days with need of mechanical ventilation after first intervention |
| Multiorgan system failure according to 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