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

Not Applicable

Completed

• Conditions: Liver Failure; Hepatitis, Chronic; Liver Cirrhosis; Hepatic Encephalopathy
• Interventions: Device: MARS; Drug: Standard Medical Therapy

• Registration Number: NCT00287235
• Lead Sponsor: Vantive Health LLC

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2000-09
• Primary Completion: 2003-11
• Study Completion: 2004-04
• Study First Submitted: 2006-02-02
• Study First Submitted QC: 2006-02-02
• Study First Posted: 2006-02-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

Exclusion Criteria

1. 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
2. Hemodynamically unstable or on vasopressor agents for blood pressure support (except for renal-dosed dopamine)
3. On acute or chronic hemodialysis or continuous renal replacement therapy (CRRT)
4. Pregnancy
5. Inability to obtain informed consent
6. Uncontrolled sepsis as defined by hemodynamic instability
7. Post-liver transplant
8. Fulminant hepatic failure
9. Irreversible brain damage as indicated by the neurologic examination and CT imaging
10. Endocarditis
11. Pulmonary edema
12. Massive aspiration pneumonia secondary to Hepatic Encephalopathy
13. Active alcohol consumption as determined by a positive blood ethanol level on enrollment/admission
14. Acute main portal vein thrombosis in patients with Hepatocellular Carcinoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Standard Medical Therapy + MARS	Standard Medical Therapy	Patients who were randomized to Group 1 received daily MARS treatments in addition to Standard Medical Therapy for 5 consecutive days.
Group 2: Standard Medical Therapy Only	Standard Medical Therapy	Patients who were randomized to Group 2 received standard medical treatment only.
Group 1: Standard Medical Therapy + MARS	MARS	Patients who were randomized to Group 1 received daily MARS treatments in addition to Standard Medical Therapy for 5 consecutive days.

Primary Outcome Measures

Name	Time	Method
Two-point reduction in HE score from the randomization grade	Within the five-day treatment period	The primary outcome measure was a two-point reduction in HE score from the the randomization grade (i.e. Grade 4 improved to at least Grade 2 and Grade 3 improved to at least Grade 1). Two summary statistics were used in the analysis: 1) The proportion of HE readings within the five-day treatment period showing an improvement of at least two points over baseline 2) The time from admission to the first two-point improvement in HE score.

Secondary Outcome Measures

Name	Time	Method
Magnitude, duration and time of improvement in Hepatic Encephalopathy	Within the five-day treatment period
Cognitive function and functional status of patients	Within the five-day treatment period
Renal function, serum bilirubin, bile acids, prothrombin activity and the hemodynamics of patients with Hepatic Encephalopathy	Within the five-day treatment period

Trial Locations

Locations (8)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

University Hospital of Copenhagen, Rigshospitalet; 🇩🇰 Copenhagen, Denmark

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

University of California, San Diego; 🇺🇸 San Diego, California, United States

UZ Gasthuisberg; 🇧🇪 Leuven, Belgium

Northwestern University; 🇺🇸 Chicago, Illinois, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Columbia-Presbyterian Medical Center; 🇺🇸 New York, New York, United States