Clinical trial NCT01079104: Hepa Wash Treatment of Patients With Hepatic Dysfunction in Intensive Care Units
Official title: Hepa Wash Treatment of Patients With Hepatic Dysfunction in Intensive Care Units
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Dysfunction
Critical Illness
Keywords: Liver failure
Hepatic insufficiency
Artificial liver
Albumin dialysis
Lead sponsor: Hepa Wash GmbH
Sponsor class: INDUSTRY
First posted: 2010-03-02
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 30-day mortality rate
timeFrame: 30 days
Secondary outcomes:
measure: Multiorgan system failure according to the Sequential Organ Failure Assessment (SOFA) Score
timeFrame: 72 hours
measure: Adverse Events
timeFrame: 30 days
measure: Number of days on ventilation
timeFrame: 30 days
measure: Number of days without extracorporeal treatment
timeFrame: 30 days
measure: 180d-mortality rate
timeFrame: 180 days
measure: 1y-mortality rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Munich
country: Germany
facility: II Medizinische Klinik, Klinikum rechts der Isar
state: Bavaria
Study officials:
affiliation: II Medizinische Klinik, Klinikum rechts der Isar, Munich
name: Wolfgang Huber, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.