Hepa Wash Treatment of Patients With Hepatic Dysfunction in Intensive Care Units (HEPATICUS-2)

This study has been terminated.
(The foundations of our pilotstudy planning has changed.)
Sponsor:
Information provided by (Responsible Party):
Hepa Wash GmbH
ClinicalTrials.gov Identifier:
NCT01079104
First received: March 1, 2010
Last updated: December 30, 2014
Last verified: December 2014
  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
Liver Dysfunction
Critical Illness
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 ]

Enrollment: 7
Study Start Date: September 2010
Study Completion Date: October 2013
Primary Completion Date: August 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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Bilirubin ≥ 2 mg/dl AND
  2. SOFA-score ≥ 9 calculated 12 hours after initiating medical resuscitation measures AND
  3. Patient is in the intensive care unit AND
  4. Signed informed consent of the patient or legal representative AND
  5. Patients are 18 years or older AND
  6. Enrollment of patients within 96 hours of fulfilling inclusion criteria (1-3).

Exclusion Criteria:

  1. Patient with known history of chronic liver disease
  2. Untreatable extrahepatic cholestasis
  3. 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.
  4. PaO2/FIO2 ≤ 100 mmHg
  5. Patients on kidney dialysis
  6. Patients with MELD-score of 40
  7. Mean arterial pressure ≤ 50 mmHg despite conventional medical treatment
  8. Patient testament excludes the use of life-prolonging measures
  9. Post-operative patients whose liver failure is related to liver surgery
  10. Uncontrolled seizures
  11. Active or uncontrolled bleeding
  12. Weight ≥ 120 kg
  13. Pregnancy
  14. Patient diagnosed with Creutzfeldt-Jakob disease
  15. 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: NCT01079104

Locations
Germany
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

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: December 30, 2014
Health Authority: Germany: Ethics Commission
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 August 25, 2016