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

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.

Study Overview

• Status: Terminated
• Conditions: Critical Illness; Liver Dysfunction
• Intervention / Treatment: Procedure: Standard Medical Therapy; Device: Hepa Wash

• Study Type: Interventional
• Enrollment (Actual): 7
• 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. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Standard Medical Therapy	Procedure: Standard Medical Therapy; Standard of care treatment
Experimental: Hepa Wash; Treatment with the liver support system "Hepa Wash"	Device: 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

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
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
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

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): August 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 9, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Hepatic insufficiency; Liver failure; Artificial liver; Albumin dialysis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Liver Diseases; Critical Illness
• Other Study ID Numbers: CS002