Rifaximin Versus Lactulose in Renal Failure

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00748904
Collaborator
(none)
0
1
2
13
0

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Progressive Renal Failure
Study Start Date :
Jun 1, 2008
Anticipated Primary Completion Date :
Jul 1, 2009
Anticipated Study Completion Date :
Jul 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

35 patients receiving rifaximin

Drug: Rifaximin
400 mg orally
Other Names:
  • Xifaxin, Salix Pharmaceuticals
  • Experimental: B

    35 patients receiving lactulose

    Drug: Lactulose
    20 grams titrate to 2-3 bowel movements in one day

    Outcome Measures

    Primary Outcome Measures

    1. slower progression to severe hepatic encephalopathy, stage 3 or 4 [during hospitalization]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • cirrhosis of liver of any etiology

    • progressive renal failure

    • stage 0-2 hepatic encephalopathy

    Exclusion Criteria:
    • pregnant women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Weill Cornell Medical Center New York New York United States 10021

    Sponsors and Collaborators

    • Weill Medical College of Cornell University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Weill Medical College of Cornell University
    ClinicalTrials.gov Identifier:
    NCT00748904
    Other Study ID Numbers:
    • 0801009635
    First Posted:
    Sep 9, 2008
    Last Update Posted:
    Feb 8, 2022
    Last Verified:
    Jan 1, 2022
    Keywords provided by Weill Medical College of Cornell University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 8, 2022