Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

238 Participants
are divided into 2 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