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Clinical Trials in Belgium / NCT04073290
Recruiting Phase 4

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

NCT04073290 · tracked via the Priya Life Science Belgium tracker
Phase
Phase 4
Started
2020-01-21
Last updated
2025-01-28

Condition(s) studied

Hepatic EncephalopathyCirrhosis, LiverPortal HypertensionLiver DiseasesPathological Processes

Investigational drug(s) / intervention(s)

Rifaximin 550 milligram Oral Tablet [XIFAXAN] →Placebo oral tabletLactulose 667 milligram/milliliter Oral Solution →

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)

Trial sites (6)

FacilityCityRegionStatus
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

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Official registry record

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.

View NCT04073290 on ClinicalTrials.gov ↗ ← All trials in Belgium