Tests rifaximin and lactulose to prevent brain problems after a liver shunt procedure
Tests rifaximin and lactulose against placebo in adults with cirrhosis having a TIPS procedure.
Plain-language title generated from the registry record
Registry title: Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose
Key facts
- Where
- Edegem and Leuven, BelgiumSee the 2 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT04073290, who can take part
Where in Belgium
- University Of AntwerpEdegem, BelgiumTaking people
- Katholieke Universiteit te LeuvenLeuven, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Trial code
- NCT04073290EU 2024-512040-28-01
- Record updated
- 28 January 2025
- Original description
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.Read full original descriptionShow less
Prevention of Hepatic Encephalopathy by Administration of Rifaximin and Lactulose in Patients With Liver Cirrhosis Undergoing TIPS Placement: a Multi-centre Randomized, Double Blind, Placebo Controlled 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.
Inclusion: Elective TIPS placement for refractory ascites or recurrent variceal bleeding:; Recurrent tense ascites and one or more of the following criteria:; Not responding to the maximal dose of diuretics (400 milligram spironolactone and 160 milligram furosemide); Kidney insufficiency (Creatinine > 135 umol/L) induced by diuretics. iii. Electrolyte disturbances (Sodium < 125 mmol/L, Potassium > 5.5 mmol/L) induced by diuretics; 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:; 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: Life-threatening variceal bleeding with emergency TIPS placement which can not be delayed 72 hours; Non-cirrhotic portal hypertension; Portal vein thrombosis (main trunk); HIV; Overt neurologic diseases such as Alzheimer's disease, Parkinson's disease; Age > 80 years; Any absolute contraindications for TIPS placement; Use of ciclosporin; Current or recent (<3 months) use of rifaximin; Pregnant or breastfeeding women; Patients refusing or unable to sign informed consent.