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

Study Overview
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Brief Summary
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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.

Official Title
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Hepa Wash Treatment of Patients With Acute-on-Chronic Liver Failure in Intensive Care Units

Conditions
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Acute on Chronic Hepatic Failure

Intervention / Treatment
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* Device: ADVOS (Hepa Wash)
* Procedure: Standard Medical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with documented clinical or histological evidence of cirrhosis AND Acute decompensation in previously stable cirrhotic liver disease AND Bilirubin ≥ 2 mg/dl AND SOFA ≥ 9 calculated after 12 hours of optimal medical therapy AND Patient is in the intensive care unit AND Informed consent of the patient or the legal representative AND Patients are 18y or older AND Enrollment of patients within 96 hours of fulfilling inclusion criteria (1-5) Exclusion Criteria: Untreatable extrahepatic cholestasis 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. PaO2/FIO2 ≤ 100 mmHg (respiratory SOFA-score of 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) Patients with creatinine ≥5 mg/dl or urine output <200 ml/day (renal SOFA-score of 4) Patients on kidney dialysis Patient with MELD-score of 40 Mean arterial pressure ≤ 50 mmHg despite conventional medical treatment Patient testament excludes the use of life-prolonging measures Post-operative patients whose liver failure is related to liver surgery Uncontrolled seizures Active or uncontrolled bleeding Weight ≥ 120 kg Pregnancy Patient diagnosed with Creutzfeldt-Jakob disease Participation in another clinical study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADVOS (Hepa Wash)<br>Treatment with the liver support system Hepa Wash | Device: ADVOS (Hepa Wash)<br>* Intervention frequency: 1-10 treatments (decision of the investigator) Duration of intervention per patient: Treatment until recovery or death (max. 6 weeks)<br>* Other names: the HIP1001 system;Procedure: Standard Medical Therapy<br>* Standard of care treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality rate | Mortality 30 days after the first intervention | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiorgan system failure according to Sequential Organ Failure Assessment (SOFA) Score | 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. | 72 hours | 
| Safety (adverse events and surrogate parameters) | 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. | 30 days | 
| Number of days on ventilation | Number of days with need of mechanical ventilation after first intervention | 30 days | 
| Number of days without extracorporeal treatment | Number of days without the need of extracorporeal renal and/or liver replacement therapy after the first intervention | 30 days | 
| 180d-mortality rate | Mortality 180 days after the first intervention | 180 days | 
| 1y-mortality rate | Mortality 1 year after the first intervention | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver failure, Hepatic insufficiency, Liver Cirrhosis, Artificial liver, Albumin dialysis