Back to resultsEfficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)
Primary Purpose
Hepatic Encephalopathy, Liver Failure, Hepatitis, Chronic
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MARS
Standard Medical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Encephalopathy focused on measuring Hepatic Encephalopathy, End Stage Liver Disease, Cirrhosis, MARS, Albumin Dialysis
Eligibility Criteria
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
Sites / Locations
- University of Alabama
- University of California, San Diego
- Northwestern University
- University of Michigan
- Columbia-Presbyterian Medical Center
- University of Virginia
- UZ Gasthuisberg
- University Hospital of Copenhagen, Rigshospitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1: Standard Medical Therapy + MARS
Group 2: Standard Medical Therapy Only
Arm Description
Patients who were randomized to Group 1 received daily MARS treatments in addition to Standard Medical Therapy for 5 consecutive days.
Patients who were randomized to Group 2 received standard medical treatment only.
Outcomes
Primary Outcome Measures
Two-point reduction in HE score from the randomization grade
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
Cognitive function and functional status of patients
Renal function, serum bilirubin, bile acids, prothrombin activity and the hemodynamics of patients with Hepatic Encephalopathy
Full Information
NCT ID
NCT00287235
First Posted
February 2, 2006
Last Updated
April 4, 2017
Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Renal Products, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00287235
Brief Title
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
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
April 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Renal Products, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy, Liver Failure, Hepatitis, Chronic, Liver Cirrhosis
Keywords
Hepatic Encephalopathy, End Stage Liver Disease, Cirrhosis, MARS, Albumin Dialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Standard Medical Therapy + MARS
Arm Type
Experimental
Arm Description
Patients who were randomized to Group 1 received daily MARS treatments in addition to Standard Medical Therapy for 5 consecutive days.
Arm Title
Group 2: Standard Medical Therapy Only
Arm Type
Active Comparator
Arm Description
Patients who were randomized to Group 2 received standard medical treatment only.
Intervention Type
Device
Intervention Name(s)
MARS
Other Intervention Name(s)
ECAD, Extracorporeal Albumin Dialysis
Intervention Type
Drug
Intervention Name(s)
Standard Medical Therapy
Other Intervention Name(s)
SMT
Primary Outcome Measure Information:
Title
Two-point reduction in HE score from the randomization grade
Description
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.
Time Frame
Within the five-day treatment period
Secondary Outcome Measure Information:
Title
Magnitude, duration and time of improvement in Hepatic Encephalopathy
Time Frame
Within the five-day treatment period
Title
Cognitive function and functional status of patients
Time Frame
Within the five-day treatment period
Title
Renal function, serum bilirubin, bile acids, prothrombin activity and the hemodynamics of patients with Hepatic Encephalopathy
Time Frame
Within the five-day treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek Hassanein, MD
Organizational Affiliation
University of California San Diego Medical Center (UCSD)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8707
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Columbia-Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
UZ Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
University Hospital of Copenhagen, Rigshospitalet
City
Copenhagen
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
17975845
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.
Results Reference
result
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Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)
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