Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)

Completed · Not applicable

Conditions studied: Hepatic Encephalopathy, Liver Failure, Hepatitis, Chronic, Liver Cirrhosis

In brief

The primary objective of the study was to compare the efficacy, safety and tolerability of Extracorporeal Albumin Dialysis (ECAD) using the Molecular Adsorbent Recirculating System (MARS®) device in improving severe HE by 2 grades compared to Standard Medical Therapy (SMT) in patients with chronic End Stage Liver Disease (ESLD) during a 5 day study period.

Key facts

Study ID

NCT00287235

Run by

Vantive Health LLC

People needed

70

Starts

2000-09-01

Expected to finish

2004-04-01

Last updated by the study team

2025-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed written informed consent by patient or patient's legally appointed representative
• Be at least 18 years of age; male or female
• Have chronic end stage liver disease with worsening Hepatic Encephalopathy (Grades 3,4).

You may not qualify if…

• Clinically significant bleeding from gastrointestinal or other site within the last 24 hours and requires 2 or more units of blood to maintain a stable hemoglobin level
• Hemodynamically unstable or on vasopressor agents for blood pressure support (except for renal-dosed dopamine)
• On acute or chronic hemodialysis or continuous renal replacement therapy (CRRT)
• Pregnancy
• Inability to obtain informed consent
• Uncontrolled sepsis as defined by hemodynamic instability
• Post-liver transplant
• Fulminant hepatic failure
• Irreversible brain damage as indicated by the neurologic examination and CT imaging
• Endocarditis
• Pulmonary edema
• Massive aspiration pneumonia secondary to Hepatic Encephalopathy
• Active alcohol consumption as determined by a positive blood ethanol level on enrollment/admission
• Acute main portal vein thrombosis in patients with Hepatocellular Carcinoma

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• University of California, San Diego — San Diego, California, United States
• Northwestern University — Chicago, Illinois, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Columbia-Presbyterian Medical Center — New York, New York, United States
• University of Virginia — Charlottesville, Virginia, United States
• UZ Gasthuisberg — Leuven, Belgium
• University Hospital of Copenhagen, Rigshospitalet — Copenhagen, Denmark

Full record on ClinicalTrials.gov

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