Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose
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.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
238 participants
Jan 21, 2020
INTERVENTIONAL
Conditions
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
Plain Language Summary
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Interventions
Rifaximin 550 milligram b.i.d. 72 hours before TIPS placement till 3 months post-TIPS
Placebo b.i.d. 72 hours before TIPS placement till 3 months post-TIPS
Lactulose based on soft stool frequency, 72 hours before TIPS placement till 3 months post-TIPS
Locations(6)
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NCT04073290