About this trial
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.
Eligibility criteria
Qualifiers
Age ≥18 years
Confirmed liver cirrhosis as documented by liver biopsy, elastography (e.g. Fibroscan) or combination of usual radiological and biochemical criteria.
Signed informed consent
Disqualifiers
Any absolute contraindications for TIPS placement
Use of ciclosporin
Life-threatening variceal bleeding with emergency TIPS placement which can not be delayed 72 hours
Age > 80 years
Trial design
Treatments tested in this trial
- Rifaximin 550 milligram Oral Tablet [XIFAXAN]
- Placebo oral tablet
- Lactulose 667 milligram/milliliter Oral Solution
Treatment groups
Sponsors and collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
Erasmus Medical Center
Collaborator
Leiden University Medical Center
Collaborator
Maastricht University Medical Center
Collaborator
Radboud University Medical Center
Collaborator
University Medical Center Groningen
Collaborator
Universitaire Ziekenhuizen KU Leuven
Collaborator
Norgine
Collaborator