Rifaximin Versus Lactulose in Renal Failure

Weill Cornell Medicine (WCM)

Status and phase: Withdrawn; Phase 4

Conditions: Renal Failure; Liver Cirrhosis

Treatments: Drug: Rifaximin; Drug: Lactulose

Study type: Interventional

Funder types: Other

Identifiers

NCT00748904

0801009635

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• cirrhosis of liver of any etiology
• progressive renal failure
• stage 0-2 hepatic encephalopathy

Exclusion criteria

• pregnant women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

A

Experimental group

Description:

35 patients receiving rifaximin

Treatment:

Drug: Rifaximin

B

Experimental group

Description:

35 patients receiving lactulose

Treatment:

Drug: Lactulose