Hepa Wash Treatment of Patients With Hepatic Dysfunction in Intensive Care Units (HEPATICUS-2)

Hepa Wash

Status: Terminated

Conditions: Critical Illness; Liver Dysfunction

Treatments: Procedure: Standard Medical Therapy; Device: Hepa Wash

Study type: Interventional

Funder types: Industry

Identifiers

NCT01079104

CS002

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Control

Active Comparator group

Description:

Standard Medical Therapy

Treatment:

Procedure: Standard Medical Therapy

Hepa Wash

Experimental group

Description:

Treatment with the liver support system "Hepa Wash"

Treatment:

Device: Hepa Wash