Hepa Wash Treatment of Patients With Acute-on-Chronic Liver Failure in Intensive Care Units (HEPATICUS - 1)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Hepa Wash GmbH.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hepa Wash GmbH
ClinicalTrials.gov Identifier:
NCT01079091
First received: March 1, 2010
Last updated: July 31, 2012
Last verified: July 2012
  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

Resource links provided by NLM:


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: 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:
  • Hepa Wash procedure
  • the HIP1001 system

  Eligibility

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

Inclusion Criteria:

  1. Patients with documented clinical or histological evidence of cirrhosis AND
  2. Acute decompensation in previously stable cirrhotic liver disease AND
  3. Bilirubin ≥ 2 mg/dl AND
  4. SOFA ≥ 9 calculated after 12 hours of optimal medical therapy AND
  5. Patient is in the intensive care unit AND
  6. Informed consent of the patient or the legal representative AND
  7. Patients are 18y or older AND
  8. Enrollment of patients within 96 hours of fulfilling inclusion criteria (1-5)

Exclusion Criteria:

  1. Untreatable extrahepatic cholestasis
  2. 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.
  3. PaO2/FIO2 ≤ 100 mmHg (respiratory SOFA-score of 4)
  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)
  5. Patients with creatinine ≥5 mg/dl or urine output <200 ml/day (renal SOFA-score of 4)
  6. Patients on kidney dialysis
  7. Patient with MELD-score of 40
  8. Mean arterial pressure ≤ 50 mmHg despite conventional medical treatment
  9. Patient testament excludes the use of life-prolonging measures
  10. Post-operative patients whose liver failure is related to liver surgery
  11. Uncontrolled seizures
  12. Active or uncontrolled bleeding
  13. Weight ≥ 120 kg
  14. Pregnancy
  15. Patient diagnosed with Creutzfeldt-Jakob disease
  16. Participation in another clinical study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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: 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 September 18, 2014