Rifaximin Versus Lactulose in Renal Failure
Information source: Weill Medical College of Cornell University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Liver Cirrhosis; Renal Failure
Intervention: Rifaximin (Drug); Lactulose (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Weill Medical College of Cornell University Overall contact:
Samuel Sigal, MD, Phone: 212-746-4129, Email: shs2015@nyp.org
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.
Clinical Details
Official title: A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Progressive Renal Failure
Study design: Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: slower progression to severe hepatic encephalopathy, stage 3 or 4
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- cirrhosis of liver of any etiology
- progressive renal failure
- stage 0-2 hepatic encephalopathy
Exclusion Criteria:
- pregnant women
Locations and Contacts
Samuel Sigal, MD, Phone: 212-746-4129, Email: shs2015@nyp.org
Weill Cornell Medical Center, New York, New York 10021, United States; Recruiting
Samuel Sigal, MD, Phone: 212-746-4129, Email: shs2015@nyp.org
Amy Tilara, MD, Phone: 646-713-7284, Email: amy.tilara@gmail.com
Samuel Sigal, MD, Principal Investigator
Amy Tilara, MD, Sub-Investigator
Ilan Weisberg, MD, Sub-Investigator
Melanie Starcic, PA, Sub-Investigator
Additional Information
Starting date: June 2008
Ending date: July 2009
Last updated: September 8, 2008
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