Rifaximin Versus Lactulose in Renal Failure

Overview

The purpose of this study is to evaluate patients with cirrhosis of the liver and renal failure and determine if the administration of rifaximin as compared to lactulose is associated with less frequent and/or slower progression to severe hepatic encephalopathy. If one is associated with lower blood ammonia levels. And, if one is associated with lower breath hydrogen and methane levels.

Full Title of Study: “A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Progressive Renal Failure”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2009

Interventions

  • Drug: Rifaximin
    • 400 mg orally
  • Drug: Lactulose
    • 20 grams titrate to 2-3 bowel movements in one day

Arms, Groups and Cohorts

  • Experimental: A
    • 35 patients receiving rifaximin
  • Experimental: B
    • 35 patients receiving lactulose

Clinical Trial Outcome Measures

Primary Measures

  • slower progression to severe hepatic encephalopathy, stage 3 or 4
    • Time Frame: during hospitalization

Participating in This Clinical Trial

Inclusion Criteria

  • cirrhosis of liver of any etiology – progressive renal failure – stage 0-2 hepatic encephalopathy Exclusion Criteria:

  • pregnant women

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Weill Medical College of Cornell University
  • Provider of Information About this Clinical Study
    • Sponsor

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