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

Not Applicable

Terminated

• Conditions: Acute on Chronic Hepatic Failure
• Interventions: Device: ADVOS (Hepa Wash); Procedure: Standard Medical Therapy

• Registration Number: NCT01079091
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-01
• Study First Submitted QC: 2010-03-01
• Study First Posted: 2010-03-02
• Study Start: 2010-09
• Primary Completion: 2013-07
• Study Completion: 2013-10
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-03
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ADVOS (Hepa Wash)	ADVOS (Hepa Wash)	Treatment with the liver support system "Hepa Wash"
ADVOS (Hepa Wash)	Standard Medical Therapy	Treatment with the liver support system "Hepa Wash"

Primary Outcome Measures

Name	Time	Method
30-day mortality rate	30 days	Mortality 30 days after the first intervention

Secondary Outcome Measures

Name	Time	Method
180d-mortality rate	180 days	Mortality 180 days after the first intervention
1y-mortality rate	1 year	Mortality 1 year after the first intervention
Safety (adverse events and surrogate parameters)	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.
Multiorgan system failure according to Sequential Organ Failure Assessment (SOFA) Score	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.
Number of days without extracorporeal treatment	30 days	Number of days without the need of extracorporeal renal and/or liver replacement therapy after the first intervention
Number of days on ventilation	30 days	Number of days with need of mechanical ventilation after first intervention

Trial Locations

Locations (1)

II Medizinische Klinik, Klinikum rechts der Isar; 🇩🇪 Munich, Bavaria, Germany