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

Sponsor:	Hepa Wash GmbH
Information provided by:	Hepa Wash GmbH
ClinicalTrials.gov Identifier:	NCT01079091

Purpose

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.

Condition	Intervention
Acute-on-chronic Liver Failure	Device: Hepa Wash Procedure: Standard Medical Therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Hepa Wash Treatment of Patients With Acute-on-Chronic Liver Failure in Intensive Care Units

Further study details as provided by Hepa Wash GmbH:

Primary Outcome Measures:

30-day mortality rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Multiorgan system failure [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Safety (surrogate parameters) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Number of days on ventilation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Number of days without extracorporeal treatment [ Time Frame: 30 days ] [ Designated as safety issue: No ]
180d-mortality rate [ Time Frame: 180 days ] [ Designated as safety issue: No ]
1y-mortality rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	June 2010
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Control: Active Comparator Standard Medical Therapy	Procedure: Standard Medical Therapy Standard of care treatment
Hepa Wash: Experimental 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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079091

Contacts

Contact: Wolfgang Huber, PD Dr.	+49 (89) 4140 ext 2214	wolfgang.huber@lrz.tu-muenchen.de
Contact: Josef Höllthaler	+49 (89) 4140 ext 5478	josef.hoellthaler@lrz.tum.de

Locations

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

Sponsors and Collaborators

Hepa Wash GmbH

Investigators

Principal Investigator:

Wolfgang Huber, PD Dr.

II Medizinische Klinik, Klinikum rechts der Isar, Munich

More Information

No publications provided

Responsible Party:	Hepa Wash GmbH ( Chief Clinical & Regulatory Officer )
ClinicalTrials.gov Identifier:	NCT01079091 History of Changes
Other Study ID Numbers:	CS001
Study First Received:	March 1, 2010
Last Updated:	March 1, 2010
Health Authority:	Germany: Institutional Review Board; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hepa Wash GmbH:

Liver failure
Hepatic insufficiency
Liver Cirrhosis
Artificial liver
Albumin dialysis

Additional relevant MeSH terms:

Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 01, 2010