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

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ClinicalTrials.gov Identifier: NCT01079104
Recruitment Status : Terminated (The foundations of our pilotstudy planning has changed.)
First Posted : March 2, 2010
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Liver Dysfunction Critical Illness Device: Hepa Wash Procedure: Standard Medical Therapy

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hepa Wash Treatment of Patients With Hepatic Dysfunction in Intensive Care Units
Study Start Date : September 2010
Primary Completion Date : August 2013
Study Completion Date : October 2013
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 30-day mortality rate [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Multiorgan system failure [ Time Frame: 72 hours ]
  2. Safety (surrogate parameters) [ Time Frame: 30 days ]
  3. Number of days on ventilation [ Time Frame: 30 days ]
  4. Number of days without extracorporeal treatment [ Time Frame: 30 days ]
  5. 180d-mortality rate [ Time Frame: 180 days ]
  6. 1y-mortality rate [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: March 2, 2010    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014

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