Clinical trial NCT01079091: Hepa Wash Treatment of Patients With Acute-on-Chronic Liver Failure in Intensive Care Units
Official title: Hepa Wash Treatment of Patients With Acute-on-Chronic Liver Failure in Intensive Care Units
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute on Chronic Hepatic Failure
Keywords: Liver failure
Hepatic insufficiency
Liver Cirrhosis
Artificial liver
Albumin dialysis
Lead sponsor: Hepa Wash GmbH
Sponsor class: INDUSTRY
First posted: 2010-03-02
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 30-day mortality rate
timeFrame: 30 days
Secondary outcomes:
measure: Multiorgan system failure according to Sequential Organ Failure Assessment (SOFA) Score
timeFrame: 72 hours
measure: Safety (adverse events and surrogate parameters)
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.