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

March 1, 2010
July 31, 2012
September 2010
June 2013   (final data collection date for primary outcome measure)
30-day mortality rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01079091 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Hepa Wash Treatment of Patients With Acute-on-Chronic Liver Failure in Intensive Care Units
Hepa Wash Treatment of Patients With Acute-on-Chronic Liver Failure in Intensive Care Units

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute-on-chronic Liver Failure
  • 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
  • Procedure: Standard Medical Therapy
    Standard of care treatment
  • Active Comparator: Control
    Standard Medical Therapy
    Intervention: Procedure: Standard Medical Therapy
  • Experimental: Hepa Wash
    Treatment with the liver support system "Hepa Wash"
    Intervention: Device: Hepa Wash
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
Not Provided
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
 
NCT01079091
CS001
Yes
Hepa Wash GmbH
Hepa Wash GmbH
Not Provided
Principal Investigator: Wolfgang Huber, PD Dr. II Medizinische Klinik, Klinikum rechts der Isar, Munich
Hepa Wash GmbH
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP