Hepa Wash Treatment of Patients With Acute-on-Chronic Liver Failure in Intensive Care Units (HEPATICUS-1)

Hepa Wash

Status: Terminated

Conditions: Acute on Chronic Hepatic Failure

Treatments: Device: ADVOS (Hepa Wash); Procedure: Standard Medical Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01079091

CS001

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

ADVOS (Hepa Wash)

Experimental group

Description:

Treatment with the liver support system "Hepa Wash"

Treatment:

Procedure: Standard Medical Therapy

Device: ADVOS (Hepa Wash)