Hepa Wash Treatment of Patients With Acute-on-Chronic Liver Failure in Intensive Care Units (HEPATICUS - 1)
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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 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 |
- 30-day mortality rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- 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: | September 2010 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Wolfgang Huber, PD Dr. | +49 (89) 4140 ext 2214 | wolfgang.huber@lrz.tu-muenchen.de |
| Contact: Bernd Saugel, MD | +49 (89) 4140 ext 5478 | bernd.saugel@lrz.tu-muenchen.de |
| Germany | |
| II Medizinische Klinik, Klinikum rechts der Isar | Recruiting |
| Munich, Bavaria, Germany, 81675 | |
| Contact: Wolfgang Huber, PD Dr. 0049 (89) 4140 ext 2214 wolfgang.huber@lrz.tum.de | |
| Principal Investigator: | Wolfgang Huber, PD Dr. | II Medizinische Klinik, Klinikum rechts der Isar, Munich |
More Information
No publications provided
| Responsible Party: | Hepa Wash GmbH |
| ClinicalTrials.gov Identifier: | NCT01079091 History of Changes |
| Other Study ID Numbers: | CS001 |
| Study First Received: | March 1, 2010 |
| Last Updated: | July 31, 2012 |
| 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 End Stage Liver Disease Hepatic Insufficiency Liver Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013