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Withdrawn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:
|
Experimental: B 35 patients receiving lactulose |
Drug: Lactulose
20 grams titrate to 2-3 bowel movements in one day
|
Outcome Measures
Primary Outcome Measures
- 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: