Back to resultsHepa Wash Treatment of Patients With Hepatic Dysfunction in Intensive Care Units (HEPATICUS-2)
Primary Purpose
Liver Dysfunction, Critical Illness
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hepa Wash
Standard Medical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Liver Dysfunction focused on measuring Liver failure, Hepatic insufficiency, Artificial liver, Albumin dialysis
Eligibility Criteria
Inclusion Criteria:
- Bilirubin ≥ 2 mg/dl AND
- SOFA-score ≥ 9 calculated 12 hours after initiating medical resuscitation measures AND
- Patient is in the intensive care unit AND
- Signed informed consent of the patient or legal representative AND
- Patients are 18 years or older AND
- Enrollment of patients within 96 hours of fulfilling inclusion criteria (1-3).
Exclusion Criteria:
- Patient with known history of chronic liver disease
- Untreatable extrahepatic cholestasis
- 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.
- PaO2/FIO2 ≤ 100 mmHg
- Patients on kidney dialysis
- Patients with MELD-score of 40
- Mean arterial pressure ≤ 50 mmHg despite conventional medical treatment
- Patient testament excludes the use of life-prolonging measures
- Post-operative patients whose liver failure is related to liver surgery
- Uncontrolled seizures
- Active or uncontrolled bleeding
- Weight ≥ 120 kg
- Pregnancy
- Patient diagnosed with Creutzfeldt-Jakob disease
- Participation in another clinical study
Sites / Locations
- II Medizinische Klinik, Klinikum rechts der Isar
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Hepa Wash
Arm Description
Standard Medical Therapy
Treatment with the liver support system "Hepa Wash"
Outcomes
Primary Outcome Measures
30-day mortality rate
Mortality 30 days after the first intervention
Secondary Outcome Measures
Multiorgan system failure according to the Sequential Organ Failure Assessment (SOFA) Score
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.
Adverse Events
Adverse Events during the intervention will be assessed
Number of days on ventilation
Number of days with need of mechanical ventilation after first intervention
Number of days without extracorporeal treatment
Number of days without the need of extracorporeal renal and/or liver replacement therapy after the first intervention
180d-mortality rate
Mortality 180 days after the first intervention
1y-mortality rate
Mortality 1 year after the first intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01079104
Brief Title
Hepa Wash Treatment of Patients With Hepatic Dysfunction in Intensive Care Units
Acronym
HEPATICUS-2
Official Title
Hepa Wash Treatment of Patients With Hepatic Dysfunction in Intensive Care Units
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
The foundations of our pilotstudy planning has changed.
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hepa Wash GmbH
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Dysfunction, Critical Illness
Keywords
Liver failure, Hepatic insufficiency, Artificial liver, Albumin dialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standard Medical Therapy
Arm Title
Hepa Wash
Arm Type
Experimental
Arm Description
Treatment with the liver support system "Hepa Wash"
Intervention Type
Device
Intervention Name(s)
Hepa Wash
Other Intervention Name(s)
Hepa Wash procedure, the HIP1001 system
Intervention Description
Intervention frequency: 1-10 treatments (decision of the investigator)
Duration of intervention per patient: Treatment until recovery or death (max. 6 weeks)
Intervention Type
Procedure
Intervention Name(s)
Standard Medical Therapy
Intervention Description
Standard of care treatment
Primary Outcome Measure Information:
Title
30-day mortality rate
Description
Mortality 30 days after the first intervention
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Multiorgan system failure according to the Sequential Organ Failure Assessment (SOFA) Score
Description
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.
Time Frame
72 hours
Title
Adverse Events
Description
Adverse Events during the intervention will be assessed
Time Frame
30 days
Title
Number of days on ventilation
Description
Number of days with need of mechanical ventilation after first intervention
Time Frame
30 days
Title
Number of days without extracorporeal treatment
Description
Number of days without the need of extracorporeal renal and/or liver replacement therapy after the first intervention
Time Frame
30 days
Title
180d-mortality rate
Description
Mortality 180 days after the first intervention
Time Frame
180 days
Title
1y-mortality rate
Description
Mortality 1 year after the first intervention
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Bilirubin ≥ 2 mg/dl AND
SOFA-score ≥ 9 calculated 12 hours after initiating medical resuscitation measures AND
Patient is in the intensive care unit AND
Signed informed consent of the patient or legal representative AND
Patients are 18 years or older AND
Enrollment of patients within 96 hours of fulfilling inclusion criteria (1-3).
Exclusion Criteria:
Patient with known history of chronic liver disease
Untreatable extrahepatic cholestasis
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.
PaO2/FIO2 ≤ 100 mmHg
Patients on kidney dialysis
Patients with MELD-score of 40
Mean arterial pressure ≤ 50 mmHg despite conventional medical treatment
Patient testament excludes the use of life-prolonging measures
Post-operative patients whose liver failure is related to liver surgery
Uncontrolled seizures
Active or uncontrolled bleeding
Weight ≥ 120 kg
Pregnancy
Patient diagnosed with Creutzfeldt-Jakob disease
Participation in another clinical study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Huber, PD Dr.
Organizational Affiliation
II Medizinische Klinik, Klinikum rechts der Isar, Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
II Medizinische Klinik, Klinikum rechts der Isar
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
28209134
Citation
Huber W, Henschel B, Schmid R, Al-Chalabi A. First clinical experience in 14 patients treated with ADVOS: a study on feasibility, safety and efficacy of a new type of albumin dialysis. BMC Gastroenterol. 2017 Feb 16;17(1):32. doi: 10.1186/s12876-017-0569-x.
Results Reference
result
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Hepa Wash Treatment of Patients With Hepatic Dysfunction in Intensive Care Units
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