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RECRUITING
NCT04073290
PHASE4

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

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

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

238

Start Date

2020-01-21

Completion Date

2026-12-31

Last Updated

2025-01-28

Healthy Volunteers

No

Interventions

DRUG

Rifaximin 550 milligram Oral Tablet [XIFAXAN]

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

DRUG

Placebo oral tablet

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

DRUG

Lactulose 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