Clinical trial NCT01690845: Molecular Adsorbent Recirculating System (MARS®) in Hypoxic Hepatitis
Official title: Molecular Adsorbent Recirculating System (MARS®) for the Treatment of Patients With Hypoxic Hepatitis - a Prospective Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hypoxic Hepatitis
Ischemic Hepatitis
Shock Liver
Hypoxic Liver Injury
Acute Liver Failure
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-09-24
Enrollment: 40
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: Hypoxic hepatitis (HH) is reported to be the most frequent cause of elevated aminotransferase levels in hospital. Up to 10 % of critically ill patients develop HH during the course of their intensive care unit (ICU) stay. Occurrence of HH is a life threatening event and ICU-mortality is reported to be up to 60%. Early therapeutic intervention is of central prognostic importance in patients with HH to improve the hemodynamic impairment as early as possible, to reduce hyperammonemia and hepatic encephalopathy, to avoid progression of organ failure and to improve outcome. Studies reported that Molecular Adsorbent Recirculating System (MARS®) therapy improved the hemodynamic situation in patients with acute and acute on chronic liver failure. The study hypothesis is that MARS® therapy in critically ill patients with severe HH improves hepatic hemodynamics and function and consecutively the course of the disease. 40 patients with suffering of severe HH with aminotransferase levels \> 40 times the upper limit of normal of more than 12 hours will be randomized 1:1 to MARS® therapy (n=20) or conventional therapy (n=20). 4 MARS®-sessions will be performed on three consecutive days, each for at least 12 hours. Treatment will be continued under special circumstances. The maximum duration of the treatment phase is 7 days. The primary endpoint is the difference of the indocyanine plasma disappearance rate at day 7. The expected duration of the study is 2 years.


Eligibility criteria: Inclusion Criteria:

* presence of severe hypoxic hepatitis with aminotransferase levels \> 40 times the upper limit of normal
* duration of hypoxic hepatitis more than 12 hours
* age \>/= 18 years

Exclusion Criteria:

* age \< 18 years
* pregnancy
* DNR - order
* liver cirrhosis
* Cardiopulmonary resuscitation with unknown neurological outcome and/or hypoxic brain damage
* Expected survival of less than 24 hours

Primary outcomes:
measure: difference of the indocyanine plasma disappearance rate (ICG-PDR)
timeFrame: Days 1-7
Secondary outcomes:
measure: duration of vasopressor support
timeFrame: 1-28
measure: ICU - length of stay
timeFrame: 1-28
measure: hospital - length of stay
timeFrame: 1-90
measure: 7-day mortality
timeFrame: 7 days
measure: 28 day mortality
timeFrame: 28 days
measure: number of organ failure on day 7
timeFrame: 7 days
measure: number of organ failure on day 28
timeFrame: 28 days
measure: markers of liver function
timeFrame: 1-28
measure: number of vasopressor free days
timeFrame: 28 days
measure: systemic hemodynamics
timeFrame: 7 days
measure: number of complications of HH
timeFrame: 1-28
measure: biomarkers
timeFrame: 0-28
measure: duration of mechanical ventilation
timeFrame: 1-28
measure: necessity of renal replacement therapy
timeFrame: 1-28
measure: duration of renal replacement therapy
timeFrame: 1-28
measure: 90 days mortality
timeFrame: 90 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna, Dpt. of Internal Medicine 3, Div. of Gastroenterology and Hepatology
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Medical University Vienna
name: Valentin Fuhrmann, Prof
role: PRINCIPAL_INVESTIGATOR
References: