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

Sponsor

Hepa Wash GmbH (Industry)

Overall Status

Terminated

CT.gov ID

NCT01079104

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Dysfunction Critical Illness	Device: Hepa Wash Procedure: Standard Medical Therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

30-day mortality rate [30 days]
Mortality 30 days after the first intervention

Secondary Outcome Measures

Multiorgan system failure according to the Sequential Organ Failure Assessment (SOFA) Score [72 hours]
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.
Adverse Events [30 days]
Adverse Events during the intervention will be assessed
Number of days on ventilation [30 days]
Number of days with need of mechanical ventilation after first intervention
Number of days without extracorporeal treatment [30 days]
Number of days without the need of extracorporeal renal and/or liver replacement therapy after the first intervention
180d-mortality rate [180 days]
Mortality 180 days after the first intervention
1y-mortality rate [1 year]
Mortality 1 year after the first intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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