RecruitingPhase 4NCT04073290

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.


Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

238 participants

Start Date

Jan 21, 2020

Study Type

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving the medications rifaximin (an antibiotic) and lactulose (a laxative) can prevent brain confusion (called hepatic encephalopathy) after a procedure called TIPS (transjugular intrahepatic portosystemic shunt) — a procedure used to reduce pressure in veins around the liver in people with severe liver disease. **You may be eligible if...** - You have liver disease with complications such as fluid buildup in the belly (ascites) that does not respond to diuretics, or repeated bleeding from swollen veins in the esophagus (variceal bleeding) - You are scheduled to have an elective TIPS procedure to manage these complications **You may NOT be eligible if...** - You have very advanced liver failure (Child-Pugh C score above a certain level) - You have had a prior episode of significant brain confusion (overt hepatic encephalopathy) - You have other conditions that make TIPS inadvisable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRifaximin 550 milligram Oral Tablet [XIFAXAN]

Rifaximin 550 milligram b.i.d. 72 hours before TIPS placement till 3 months post-TIPS

DRUGPlacebo oral tablet

Placebo b.i.d. 72 hours before TIPS placement till 3 months post-TIPS

DRUGLactulose 667 milligram/milliliter Oral Solution

Lactulose based on soft stool frequency, 72 hours before TIPS placement till 3 months post-TIPS


Locations(6)

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

Academic Medical Centre

Amsterdam, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Leiden University Medical Center

Leiden, Netherlands

Radboud University

Nijmegen, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

View Full Details on ClinicalTrials.gov

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NCT04073290


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