Hepa Wash Treatment of Patients With Hepatic Dysfunction in Intensive Care Units (HEPATICUS - 2)
This study is currently recruiting participants.
Verified July 2012 by Hepa Wash GmbH
Sponsor:
Hepa Wash GmbH
Information provided by (Responsible Party):
Hepa Wash GmbH
ClinicalTrials.gov Identifier:
NCT01079104
First received: March 1, 2010
Last updated: July 31, 2012
Last verified: July 2012
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Purpose
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 | Intervention |
|---|---|
|
Hepatic Dysfunction in Critically Ill Patients |
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 Hepatic Dysfunction 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: | 184 |
| 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 |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079104
Contacts
| 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 |
Locations
| 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 | |
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 |
| ClinicalTrials.gov Identifier: | NCT01079104 History of Changes |
| Other Study ID Numbers: | CS002 |
| 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 Artificial liver Albumin dialysis |
Additional relevant MeSH terms:
|
Critical Illness Liver Diseases Disease Attributes Pathologic Processes Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013