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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Intervention frequency: 1-10 treatments (decision of the investigator) Duration of intervention per patient: Treatment until recovery or death (max. 6 weeks)
Standard of care treatment
II Medizinische Klinik, Klinikum rechts der Isar
Munich, Bavaria, Germany
30-day mortality rate
Mortality 30 days after the first intervention
Time frame: 30 days
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.
Time frame: 72 hours
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.
Time frame: 30 days
Number of days on ventilation
Number of days with need of mechanical ventilation after first intervention
Time frame: 30 days
Number of days without extracorporeal treatment
Number of days without the need of extracorporeal renal and/or liver replacement therapy after the first intervention
Time frame: 30 days
180d-mortality rate
Mortality 180 days after the first intervention
Time frame: 180 days
1y-mortality rate
Mortality 1 year after the first intervention
Time frame: 1 year
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