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

Acute on Chronic Hepatic Failure Clinical Trial

— HEPATICUS-1  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01079091
• Other study ID #: CS001
• Status: Terminated
• Phase: N/A
• Start date: September 2010
• Est. completion date: October 2013

Study information

• Verified date: July 2019
• Source: Hepa Wash GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: October 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute on Chronic Hepatic Failure
• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Hepatic Insufficiency
• Liver Failure

Intervention

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)

Procedure:
• Standard Medical Therapy
Standard of care treatment

Locations

Country	Name	City	State
Germany	II Medizinische Klinik, Klinikum rechts der Isar	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Hepa Wash GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality rate	Mortality 30 days after the first intervention	30 days
Secondary	Multiorgan system failure according to 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.	72 hours
Secondary	Safety (adverse events and surrogate parameters)	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.	30 days
Secondary	Number of days on ventilation	Number of days with need of mechanical ventilation after first intervention	30 days
Secondary	Number of days without extracorporeal treatment	Number of days without the need of extracorporeal renal and/or liver replacement therapy after the first intervention	30 days
Secondary	180d-mortality rate	Mortality 180 days after the first intervention	180 days
Secondary	1y-mortality rate	Mortality 1 year after the first intervention	1 year