Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis.
Harry D Zacharias, Fady Kamel, Jaclyn Tan...
https://pubmed.ncbi.nlm.nih.gov/37467180Actively Recruiting
Phase 4
Age: 18Years - 80Years
All Genders
ID04073290
Prevention of Hepatic Encephalopathy by Administration of Rifaximin and Lactulose in Patients With Liver Cirrhosis Undergoing TIPS Placement: a Multi-centre Randomized, Double Blind, Placebo Controlled Trial
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-01-28
238
Participants Needed
6
Research Sites
13 weeks
Total Duration
On this page
Sponsors
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
E
Erasmus Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Hepatic encephalopathy (HE) is a common and serious complication in patients with liver cirrhosis, which often occurs after Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement used to treat portal hypertension complications like variceal bleeding or refractory ascites. This research evaluates whether giving the drugs rifaximin and lactulose before and after TIPS can reduce the occurrence of overt HE (OHE) during the first three months after the procedure. The study is a multicenter, randomized, double-blind, placebo-controlled trial conducted in several academic centers in the Netherlands and Belgium. Participants are randomly assigned to receive either rifaximin 550 mg twice daily combined with lactulose or a placebo combined with lactulose. The treatment starts 72 hours before TIPS placement and continues for three months after the procedure. Lactulose dosing is adjusted to ensure no more than two soft stools per day. The control group receives placebo plus lactulose following the same schedule. The study also monitors secondary outcomes such as mortality at 90 days, survival without transplant, recurrent HE episodes, changes in neurocognitive tests, blood molecular differences, and quality of life. During the study, participants undergo regular assessments including neurocognitive tests like the Psychometric Hepatic Encephalopathy Score and the one-minute animal naming test. Blood samples are collected to analyze molecular changes. The primary outcome is the development of overt HE within three months after TIPS. Follow-up continues up to one year to evaluate additional episodes of HE, survival, and quality of life. Participants are monitored closely for safety and adherence to study treatments throughout the trial period.
CONDITIONS
Brief Title
Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Elective TIPS placement for refractory ascites or recurrent variceal bleeding with specific clinical criteria
- Age 18 to 80 years
- Confirmed liver cirrhosis documented by liver biopsy, elastography, or standard radiological and biochemical criteria
- Signed informed consent
You will not qualify if you...
- Any absolute contraindications for TIPS placement
- Use of ciclosporin
- Life-threatening variceal bleeding requiring emergency TIPS placement that cannot be delayed 72 hours
- Age over 80 years
- Non-cirrhotic portal hypertension
- Main trunk portal vein thrombosis
- HIV infection
- Current or recent (within 3 months) use of rifaximin
- Overt neurological diseases such as Alzheimer's or Parkinson's disease
- Pregnant or breastfeeding women
- Patients refusing or unable to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
Duration - 3 days
Participants begin taking rifaximin or placebo combined with lactulose 72 hours before TIPS placement.
1 visit before TIPS placement
Treatment
Duration - Approximately 3 months
Participants receive rifaximin or placebo combined with lactulose starting 72 hours before TIPS placement and continuing for 3 months after the procedure.
Visits as scheduled during treatment period
Follow-up
Duration - Up to 9 months after treatment ends
Participants are followed for up to 12 months after TIPS placement to monitor for hepatic encephalopathy episodes, survival, and other outcomes.
Regular visits during follow-up period
Trial Site Locations
Total: 6 locations
1
Universitaire Ziekenhuizen Leuven
Leuven, Belgium
Actively Recruiting
2
Academic Medical Centre
Amsterdam, Netherlands
Actively Recruiting
3
University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
4
Leiden University Medical Center
Leiden, Netherlands
Actively Recruiting
5
Radboud University
Nijmegen, Netherlands
Actively Recruiting
6
Erasmus Medical Center
Rotterdam, Netherlands
Actively Recruiting
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Research Team
K
Koos de Wit, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Prevention of hepatic encephalopathy by administration of rifaximin and lactulose in patients with liver cirrhosis undergoing placement of a transjugular intrahepatic portosystemic shunt (TIPS): a multicentre randomised, double blind, placebo controlled trial (PEARL trial).
K de Wit, J J Schaapman, F Nevens...
https://pubmed.ncbi.nlm.nih.gov/33372103