A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Renal Failure

Withdrawn before enrolling · Phase 3

Conditions studied: Hepatic Encephalopathy

In brief

The aim of the current study is to determine whether rifaximin or lactulose is more effective in preventing the development of severe hepatic encephalopathy in hospitalized patients with cirrhosis and new onset kidney failure. Subjects will be randomly assigned to one of two treatment groups: Group A: Lactulose 20g dose titrated to 2-3 soft-formed bowel movements per day Group B: Rifaximin 550mg tablet twice daily. Subjects will be followed daily for two weeks or until hospital discharge. Treatment success is defined as prevention of grade 3 or 4 HE during hospitalization.

Key facts

Study ID

NCT02086825

Run by

NYU Langone Health

People needed

0

Starts

2015-10-01

Last updated by the study team

2016-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older
• Cirrhosis of the liver based on biopsy or clinical and radiographic criteria
• Ability to provide informed consent (Grade 0 to 1 HE)
• Acute renal failure (increase in baseline creatinine of 0.5mg/dL to a value of >2.0 mg/dL within 3 days).
• Absence of improvement in renal function after adequate fluid resuscitation using either normal saline or blood products (25% salt poor albumin, fresh frozen plasma, or packed red blood cells)

You may not qualify if…

• Previous history of sensitivity/allergy to lactulose or rifaximin or rifampin
• Pregnancy
• Inability to obtain informed consent

Where it is running

• New York University Langone Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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