Hepa Wash Treatment of Patients With Hepatic Dysfunction in Intensive Care Units

Study Overview
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Brief Summary
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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.

Official Title
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Hepa Wash Treatment of Patients With Hepatic Dysfunction in Intensive Care Units

Conditions
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Liver Dysfunction, Critical Illness

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bilirubin ≥ 2 mg/dl AND SOFA-score ≥ 9 calculated 12 hours after initiating medical resuscitation measures AND Patient is in the intensive care unit AND Signed informed consent of the patient or legal representative AND Patients are 18 years or older AND Enrollment of patients within 96 hours of fulfilling inclusion criteria (1-3). Exclusion Criteria: Patient with known history of chronic liver disease 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 Patients on kidney dialysis Patients 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Standard Medical Therapy | Procedure: Standard Medical Therapy<br>* Standard of care treatment<br>|
| Experimental: Hepa Wash<br>Treatment with the liver support system Hepa Wash | Device: 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;|

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 the 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 | 
| Adverse Events | Adverse Events during the intervention will be assessed | 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, Artificial liver, Albumin dialysis