Clinical trial NCT00287235: Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)
Official title: A Prospective, Controlled Study Of The Clinical Efficacy Of Albumin Dialysis Using The Molecular Adsorbent Recirculating System (MARS®) For The Treatment Of Patients With Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Encephalopathy
Liver Failure
Hepatitis, Chronic
Liver Cirrhosis
Keywords: Hepatic Encephalopathy
End Stage Liver Disease
Cirrhosis
MARS
Albumin Dialysis
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Gambro Renal Products, Inc.
name: Baxter Healthcare Corporation
First posted: 2006-02-06
Enrollment: 70
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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Two-point reduction in HE score from the randomization grade
timeFrame: Within the five-day treatment period
Secondary outcomes:
measure: Magnitude, duration and time of improvement in Hepatic Encephalopathy
timeFrame: Within the five-day treatment period
measure: Cognitive function and functional status of patients
timeFrame: Within the five-day treatment period
measure: Renal function, serum bilirubin, bile acids, prothrombin activity and the hemodynamics of patients with Hepatic Encephalopathy
timeFrame: Within the five-day treatment period
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: New York
country: United States
facility: Columbia-Presbyterian Medical Center
state: New York
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Copenhagen
country: Denmark
facility: University Hospital of Copenhagen, Rigshospitalet
Study officials:
affiliation: University of California San Diego Medical Center (UCSD)
name: Tarek Hassanein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hassanein TI, Tofteng F, Brown RS Jr, McGuire B, Lynch P, Mehta R, Larsen FS, Gornbein J, Stange J, Blei AT. Randomized controlled study of extracorporeal albumin dialysis for hepatic encephalopathy in advanced cirrhosis. Hepatology. 2007 Dec;46(6):1853-62. doi: 10.1002/hep.21930.