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
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Elective TIPS placement for refractory ascites or recurrent variceal bleeding:
Recurrent tense ascites and one or more of the following criteria:
i. Not responding to the maximal dose of diuretics (400 milligram spironolactone and 160 milligram furosemide).
ii. Kidney insufficiency (Creatinine \> 135 umol/L) induced by diuretics. iii. Electrolyte disturbances (Sodium \< 125 mmol/L, Potassium \> 5.5 mmol/L) induced by diuretics.
iv. Not tolerating higher dose of diuretics (e.g. because of subjective side effects like muscle cramps).
Recurrent variceal bleeding, not responsive to treatment with endoscopic band ligation and beta-blockers, with a high risk of failure of endoscopic treatment:
i. Patients with a variceal bleeding and Child-Pugh C (10-13 points) cirrhosis or ii. Patients with a variceal bleeding, Child-Pugh B and an active bleeding during endoscopy
2. Age ≥18 years
3. Confirmed liver cirrhosis as documented by liver biopsy, elastography (e.g. Fibroscan) or combination of usual radiological and biochemical criteria.
4. Signed informed consent
Exclusion Criteria:
1. Any absolute contraindications for TIPS placement
2. Use of ciclosporin
3. Life-threatening variceal bleeding with emergency TIPS placement which can not be delayed 72 hours
4. Age \> 80 years
5. Non-cirrhotic portal hypertension
6. Portal vein thrombosis (main trunk)
7. HIV
8. Current or recent (\<3 months) use of rifaximin
9. Overt neurologic diseases such as Alzheimer's disease, Parkinson's disease
10. Pregnant or breastfeeding women
11. Patients refusing or unable to sign informed consent
Primary outcome measure(s)
post-TIPS Hepatic Encephalopathy — First 3 months after TIPS placement post-TIPS Hepatic Encephalopathy
Trial sites (6)
Facility
City
Region
Status
Universitaire Ziekenhuizen Leuven
Leuven
Belgium
Recruiting
Academic Medical Centre
Amsterdam
Netherlands
Recruiting
University Medical Center Groningen
Groningen
Netherlands
Recruiting
Leiden University Medical Center
Leiden
Netherlands
Recruiting
Radboud University
Nijmegen
Netherlands
Recruiting
Erasmus Medical Center
Rotterdam
Netherlands
Recruiting
More Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) trials in Belgium
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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