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Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Summary
Rationale: Hepatic encephalopathy (HE) is a major and common complication in patients with liver cirrhosis. HE can be classified in the extensive range of neurocognitive deterioration as minimal HE (MHE), covert HE (grade I), or overt HE (OHE, grade II-IV). Liver cirrhosis is the most common cause of portal hypertension (PH). Patients who develop complications of PH, like variceal bleeding or refractory ascites, can benefit from a Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement. Unfortunately, post-TIPS HE is a common and often severe complication. Incidence of new onset or worsening of HE after TIPS is approximately 20-45%. Currently there is no strategy to prevent post-TIPS HE.
Official title: 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.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
238
Start Date
2020-01-21
Completion Date
2026-12-31
Last Updated
2025-01-28
Healthy Volunteers
No
Conditions
Interventions
Rifaximin 550 milligram Oral Tablet [XIFAXAN]
Rifaximin 550 milligram b.i.d. 72 hours before TIPS placement till 3 months post-TIPS
Placebo oral tablet
Placebo b.i.d. 72 hours before TIPS placement till 3 months post-TIPS
Lactulose 667 milligram/milliliter Oral Solution
Lactulose based on soft stool frequency, 72 hours before TIPS placement till 3 months post-TIPS
Locations (6)
Universitaire Ziekenhuizen Leuven
Leuven, Belgium
Academic Medical Centre
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Radboud University
Nijmegen, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands