Overview

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

Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
New York University School of Medicine
NYU Langone Health
Treatments:
Lactulose
Rifamycins
Rifaximin
Criteria
Inclusion Criteria:

1. Age 18 years or older

2. Cirrhosis of the liver based on biopsy or clinical and radiographic criteria

3. Ability to provide informed consent (Grade 0 to 1 HE)

4. Acute renal failure (increase in baseline creatinine of 0.5mg/dL to a value of >2.0
mg/dL within 3 days).

5. 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)

Exclusion Criteria:

1. Previous history of sensitivity/allergy to lactulose or rifaximin or rifampin

2. Pregnancy

3. Inability to obtain informed consent