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

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.

Study Overview

• Status: Terminated
• Conditions: Acute on Chronic Hepatic Failure
• Intervention / Treatment: Device: ADVOS (Hepa Wash); Procedure: Standard Medical Therapy

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81675
      • II Medizinische Klinik, Klinikum rechts der Isar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hepa Wash GmbH
• Investigators: Principal Investigator: Wolfgang Huber, PD Dr., II Medizinische Klinik, Klinikum rechts der Isar, Munich

Publications and helpful links

General Publications

• Huber W, Henschel B, Schmid R, Al-Chalabi A. First clinical experience in 14 patients treated with ADVOS: a study on feasibility, safety and efficacy of a new type of albumin dialysis. BMC Gastroenterol. 2017 Feb 16;17(1):32. doi: 10.1186/s12876-017-0569-x.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: March 1, 2010
• First Submitted That Met QC Criteria: March 1, 2010
• First Posted (Estimate): March 2, 2010

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Liver Cirrhosis; Hepatic insufficiency; Liver failure; Artificial liver; Albumin dialysis
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure, Acute; End Stage Liver Disease; Liver Failure; Hepatic Insufficiency; Acute-On-Chronic Liver Failure
• Other Study ID Numbers: CS001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No