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

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ClinicalTrials.gov Identifier: NCT01079091
Recruitment Status : Terminated (The foundations of our pilotstudy planning has changed.)
First Posted : March 2, 2010
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Hepa Wash GmbH

Brief Summary:
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 or disease Intervention/treatment Phase
Acute on Chronic Hepatic Failure Device: ADVOS (Hepa Wash) Procedure: Standard Medical Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hepa Wash Treatment of Patients With Acute-on-Chronic Liver Failure in Intensive Care Units
Study Start Date : September 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
Experimental: ADVOS (Hepa Wash)
Treatment with the liver support system "Hepa Wash"
Device: ADVOS (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




Primary Outcome Measures :
  1. 30-day mortality rate [ Time Frame: 30 days ]
    Mortality 30 days after the first intervention


Secondary Outcome Measures :
  1. Multiorgan system failure according to Sequential Organ Failure Assessment (SOFA) Score [ Time Frame: 72 hours ]
    The Sequential Organ Failure Assessment (SOFA) Score analyses the severity of illness according to 6 organ systems (CNS, Liver, Kidney, Hemodynamic, Coagulation, Lung). Each system is given 0 to 4 points for a total of 24 points. A value >2 in each of the systems indicates organ failure. An overall value > 14 indicates 90% probability of in-hospital mortality.

  2. Safety (adverse events and surrogate parameters) [ Time Frame: 30 days ]
    Adverse Events during the intervention will be assessed. Additionally, liver parameters (e.g. Bilirubin), Kidney Parameters (e.g. Creatinin, Urea) and blood gas analysis will be performed.

  3. Number of days on ventilation [ Time Frame: 30 days ]
    Number of days with need of mechanical ventilation after first intervention

  4. Number of days without extracorporeal treatment [ Time Frame: 30 days ]
    Number of days without the need of extracorporeal renal and/or liver replacement therapy after the first intervention

  5. 180d-mortality rate [ Time Frame: 180 days ]
    Mortality 180 days after the first intervention

  6. 1y-mortality rate [ Time Frame: 1 year ]
    Mortality 1 year after the first intervention



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

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): NCT01079091


Locations
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Germany
II Medizinische Klinik, Klinikum rechts der Isar
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Hepa Wash GmbH
Investigators
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Principal Investigator: Wolfgang Huber, PD Dr. II Medizinische Klinik, Klinikum rechts der Isar, Munich
Publications of Results:
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Responsible Party: Hepa Wash GmbH
ClinicalTrials.gov Identifier: NCT01079091    
Other Study ID Numbers: CS001
First Posted: March 2, 2010    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Keywords provided by Hepa Wash GmbH:
Liver failure
Hepatic insufficiency
Liver Cirrhosis
Artificial liver
Albumin dialysis
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Liver Diseases
Digestive System Diseases
Liver Failure, Acute