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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gambro Renal Products, Inc.
ClinicalTrials.gov Identifier:
NCT00287235
First received: February 2, 2006
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Hepatic Encephalopathy
Liver Failure
Hepatitis, Chronic
Liver Cirrhosis
Device: MARS
Drug: Standard Medical Therapy

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

Resource links provided by NLM:


Further study details as provided by Gambro Renal Products, Inc.:

Primary Outcome Measures:
  • Two-point reduction in HE score from the randomization grade [ Time Frame: Within the five-day treatment period ] [ Designated as safety issue: No ]
    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:
  • Magnitude, duration and time of improvement in Hepatic Encephalopathy [ Time Frame: Within the five-day treatment period ] [ Designated as safety issue: No ]
  • Cognitive function and functional status of patients [ Time Frame: Within the five-day treatment period ] [ Designated as safety issue: No ]
  • Renal function, serum bilirubin, bile acids, prothrombin activity and the hemodynamics of patients with Hepatic Encephalopathy [ Time Frame: Within the five-day treatment period ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: September 2000
Study Completion Date: April 2004
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: Standard Medical Therapy + MARS
Patients who were randomized to Group 1 received daily MARS treatments in addition to Standard Medical Therapy for 5 consecutive days.
Device: MARS
Other Names:
  • MARS
  • ECAD
  • Extracorporeal Albumin Dialysis
Drug: Standard Medical Therapy
Other Name: SMT
Active Comparator: Group 2: Standard Medical Therapy Only
Patients who were randomized to Group 2 received standard medical treatment only.
Drug: Standard Medical Therapy
Other Name: SMT

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287235

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, California
University of California, San Diego
San Diego, California, United States, 92103-8707
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New York
Columbia-Presbyterian Medical Center
New York, New York, United States, 10032
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Belgium
UZ Gasthuisberg
Leuven, Belgium
Denmark
University Hospital of Copenhagen, Rigshospitalet
Copenhagen, Denmark
Sponsors and Collaborators
Gambro Renal Products, Inc.
Investigators
Principal Investigator: Tarek Hassanein, MD University of California San Diego Medical Center (UCSD)
  More Information

Publications:
Responsible Party: Gambro Renal Products, Inc.
ClinicalTrials.gov Identifier: NCT00287235     History of Changes
Other Study ID Numbers: MARS HE Study
Study First Received: February 2, 2006
Last Updated: June 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gambro Renal Products, Inc.:
Hepatic Encephalopathy
End Stage Liver Disease
Cirrhosis
MARS
Albumin Dialysis

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Hepatitis, Chronic
Liver Cirrhosis
Liver Failure
Brain Diseases, Metabolic
Central Nervous System Diseases
Digestive System Diseases
Hepatic Insufficiency
Hepatitis
Liver Diseases
Metabolic Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 29, 2014