A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Renal Failure
1 other identifier
interventional
N/A
1 country
1
Brief 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.
Trial Health
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2014
CompletedFirst Posted
Study publicly available on registry
March 13, 2014
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedMarch 2, 2016
March 1, 2016
1.2 years
February 11, 2014
March 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Development of Progressive Hepatic Encephalopathy to Stage 3 or 4 in patients with progressive renal failure
The primary outcome for this study is the development of progressive hepatic encephalopathy to stage 3 or 4 in patients with progressive renal failure. For the purpose of this study, acute renal failure is defined as a progressive and sustained increase in serum creatinine \>0.5mg/dl from baseline to a value of 2.0mg/dl, irrespective of etiology in 3 days. Renal failure is progressive and sustained if there is no improvement after volume resuscitation with 1.5 L of normal saline or equivalent colloid infusion (serum albumin or blood product transfusion).
90 days (including follow-ups)
Secondary Outcomes (2)
In-hospital mortality
Patient's hospital stay up to 14 days
Hospital Length of Stay
Up to 14 days
Study Arms (2)
Rifaximin
EXPERIMENTALLactulose
EXPERIMENTALInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University Langone Medical Center
New York, New York, 10010, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel Sigal
NYU MEDICAL CENTER
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2014
First Posted
March 13, 2014
Study Start
October 1, 2015
Primary Completion
December 1, 2016
Last Updated
March 2, 2016
Record last verified: 2016-03