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Personalized Nutritional Intervention in Patients Undergoing TIPS Insertion for Refractory Ascites to Prevent Overt Hepatic Encephalopathy
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Summary
This study will evaluate whether a nutritional intervention is better than another to reduce the incidence of overt hepatic encephalopathy in patients undergoing TIPS insertion for refractory ascites.
Official title: Personalized Nutritional Intervention to Prevent Overt Hepatic Encephalopathy in Patients With Cirrhosis and Refractory Ascites Who Undergo TIPS Insertion: A Multicenter Randomized Controlled Trial (SUPPRESS-HE Trial)
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-06-15
Completion Date
2029-12-15
Last Updated
2026-06-08
Healthy Volunteers
No
Interventions
High Energy and High Protein Diet 1
As participants are blinded, description of the intervention is meant to maintain the blinding. Participants will meet the study dietitian who will perform a nutritional assessment. The study dietitian will then prescribe a high-energy and high-protein diet with or without the use of oral nutritional supplements that will fit your taste preferences and dietary needs. The nutritional intervention will focus on having 3 meals per day and 3 snacks per day, including at bedtime.
High Energy and High Protein Diet 2
As participants are blinded, description of the intervention is meant to maintain the blinding. Participants will meet the study dietitian who will perform a nutritional assessment. The study dietitian will then prescribe a high-energy and high-protein diet with or without the use of oral nutritional supplements that will fit your taste preferences and dietary needs. The nutritional intervention will focus on having 3 meals per day and 3 snacks per day, including at bedtime.
Locations (1)
McGill University Health Centre
Montreal, Quebec, Canada