Clinical Trials Logo
  1. Home
  2. Ischemic Hepatitis
  3. NCT01690845

Molecular Adsorbent Recirculating System (MARS®) in Hypoxic Hepatitis — MARS in HH  

Acute Liver Failure Clinical Trial

Official title:
Molecular Adsorbent Recirculating System (MARS®) for the Treatment of Patients With Hypoxic Hepatitis - a Prospective Randomized Controlled Clinical Study

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01690845
Study type Interventional
Source Medical University of Vienna
Contact Valentin Fuhrmann, Prof
Phone 0043140400
Email valentin.fuhrmann@meduniwien.ac.at
Status Recruiting
Phase Phase 2
Start date June 2012
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05491135 - Hepatocyte Microbeads for Acute Liver Failure Phase 1/Phase 2
Terminated NCT01937130 - Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF Phase 2
Withdrawn NCT05940610 - The Safety and Efficacy of MSC-EVs in Acute/Acute-on-Chronic Liver Failure Phase 1/Phase 2
Terminated NCT01875874 - Safety and Efficacy of the ELAD System (ELAD) to Treat Acute Liver Failure (ALF) Phase 2
Not yet recruiting NCT01435421 - Breath Test for Patients With Acute Liver Disease for Early Detection of the Need for Transplant or Recovery N/A
Completed NCT00245310 - Indocyangreen Elimination in Cirrhosis and Acute Liver Failure N/A
Withdrawn NCT03629015 - Safety Study of Stemchymal® in Acute Liver Failure Phase 1
Recruiting NCT04621812 - Role of Fecal Microbiota in Predicting Graft Rejection and Sepsis Among Recipients of Living Donor Liver Transplant in First Year.
Active, not recruiting NCT02833064 - Biomarkers in Liver Failure
Not yet recruiting NCT06285253 - miroliverELAP® for the Treatment of Acute Liver Failure: A Phase 1 Trial Phase 1
Recruiting NCT03882346 - Study to Evaluate Safety and Efficacy of LifeLiver in Acute or Acute-on-Chronic Liver Failure Patients Phase 2
Recruiting NCT05689645 - F573 for Injection for the Treatment of Liver Injury/Failure Phase 2
Not yet recruiting NCT05772585 - Characterization of Metabolomic Fingerprints in Patients With Acute Liver Failure and Acute-on-chronic Liver Failure With Hepatic Encephalopathy
Completed NCT00655304 - The Effect of Prometheus (R) Liver Support Dialysis on Cerebral Metabolism in Acute Liver Failure N/A
Completed NCT00059267 - Prevention of Recurrent Hepatitis B After Liver Transplantation N/A
Active, not recruiting NCT05413083 - Evaluation of Cardiac Function in Acutely Decompensated Cirrhosis
Recruiting NCT05146336 - CytOSorb TreatMent Of Critically Ill PatientS Registry
Withdrawn NCT04089969 - Cardiac Risk Assessment Using Standard of Care Versus CTA and Heart Flow FFRct N/A
Completed NCT02460510 - Role of Hypertonic Saline Versus Mannitol in the Management of Raised Intracranial Pressure in Patients With ALF N/A
Completed NCT01872767 - Spectrum, Profile and Outcome of Infections in Patients With Cirrhosis and/ or Acute on Chronic Liver Failure N/A