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

Liver Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287235
• Other study ID #: MARS HE Study
• Status: Completed
• Phase: N/A
• First received: February 2, 2006
• Last updated: April 4, 2017
• Start date: September 2000
• Est. completion date: April 2004

Study information

• Verified date: April 2017
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2004
• Est. primary completion date: November 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Fibrosis
• Hepatic Encephalopathy
• Hepatitis, Chronic
• Liver Cirrhosis
• Liver Failure

Intervention

Device:
• MARS

Drug:
• Standard Medical Therapy

Locations

Country	Name	City	State
Belgium	UZ Gasthuisberg	Leuven
Denmark	University Hospital of Copenhagen, Rigshospitalet	Copenhagen
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Alabama	Birmingham	Alabama
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	Columbia-Presbyterian Medical Center	New York	New York
United States	University of California, San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Gambro Renal Products, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Denmark, 

References & Publications (1)

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):1853-6 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within the five-day treatment period
Secondary	Magnitude, duration and time of improvement in Hepatic Encephalopathy		Within the five-day treatment period
Secondary	Cognitive function and functional status of patients		Within the five-day treatment period
Secondary	Renal function, serum bilirubin, bile acids, prothrombin activity and the hemodynamics of patients with Hepatic Encephalopathy		Within the five-day treatment period