Personalized Nutritional Intervention in Patients Undergoing TIPS Insertion for Refractory Ascites to Prevent Overt Hepatic Encephalopathy
Key facts
- Who runs it
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Where
- Canada1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Not yet recruiting
- People taking part
- 50 people, planned
- Started
- 15 Jun 2026
- Expected to end
- 15 Dec 2029
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- High Energy and High Protein Diet 1
- High Energy and High Protein Diet 2
- Record updated
- 8 June 2026
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- Diagnosis of cirrhosis
- TIPS planned for refractory ascites
- Being at least moderately malnourished
Who cannot take part
- Previous Liver transplantation
- Budd Chiari Syndrome
- Complete or cavernomatous portal vein thrombosis
- Liver failure (MELD > 18 or Child Pugh score > 12)
- Heart failure (NYHA ≥ III or LVEF < 50%)
- Kidney failure (serum creatinine > 250µmol/L)
- TIPS insertion for other reason than refractory ascites
- Pre-TIPS recurrent or persistent overt hepatic encephalopathy
- Use of lactulose or rifaximin in the last 4 weeks
- Pregnancy or breastfeeding
- Unable to provide informed consent
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Nutrition Intervention 1Treatment being tested
As participants are blinded, description of the arm 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.
Treatment: High Energy and High Protein Diet 1
- Nutrition Intervention 2Existing treatment, for comparison
As participants are blinded, description of the arm 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.
Treatment: High Energy and High Protein Diet 2
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 doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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)
- Fit questions
- Built from NCT07634237, who can take part
- Record updated
- 8 June 2026