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

The trial was a two-group unblinded multicenter clinical trial. Patients were randomized to receive either SMT or SMT plus five days MARS® treatment. The trial design called for patients to receive a baseline hepatic encephalopathy (HE) assessment on admission, and at 12-hour intervals, giving 10 HE measurements during treatment using a refinement / adaptation of the Conn West Haven HE Criteria HE scoring system

Inclusion criteria

• 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).

Exclusion criteria

• 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