Status:
RECRUITING
Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Erasmus Medical Center
Leiden University Medical Center
Conditions:
Hepatic Encephalopathy
Cirrhosis, Liver
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 (M...
Detailed Description
Objective: To assess the incidence of post-TIPS OHE within the first three months after prophylactic administration of lactulose and rifaximin versus placebo in patients who undergo Transjugular Intra...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- Non-cirrhotic portal hypertension
- Portal vein thrombosis (main trunk)
- HIV
- Current or recent (\<3 months) use of rifaximin
- Overt neurologic diseases such as Alzheimer's disease, Parkinson's disease
- Pregnant or breastfeeding women
- Patients refusing or unable to sign informed consent
Key Trial Info
Start Date :
January 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT04073290
Start Date
January 21 2020
End Date
December 31 2026
Last Update
January 28 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Universitaire Ziekenhuizen Leuven
Leuven, Belgium
2
Academic Medical Centre
Amsterdam, Netherlands
3
University Medical Center Groningen
Groningen, Netherlands
4
Leiden University Medical Center
Leiden, Netherlands