Personalized Nutritional Intervention in Patients Undergoing TIPS Insertion for Refractory Ascites to Prevent Overt Hepatic Encephalopathy

NCT07634237 — Not applicable, Not yet recruiting, 50 participants, McGill University Health Centre/Research Institute of the McGill University Health Centre

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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)

Registry	NCT07634237, acronym SUPPRESS-HE
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	50 (Estimated)
Sponsor	McGill University Health Centre/Research Institute of the McGill University Health Centre (Other); collaborators: Canadian Institutes of Health Research (CIHR)
Conditions	Cirrhosis, Refractory Ascites, TIPS Insertion
Interventions	High Energy and High Protein Diet 1, High Energy and High Protein Diet 2 (Dietary supplement)
Dates	start 2026-06-15 (estimated), primary completion 2029-06-15 (estimated), completion 2029-12-15 (estimated), first posted 2026-06-08, last updated 2026-06-08
Locations	1 site in Canada

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Nutrition Intervention 1	Experimental	Dietary Supplement: High Energy and High Protein Diet 1	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.
Nutrition Intervention 2	Active comparator	Dietary Supplement: High Energy and High Protein Diet 2	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.

High Energy and High Protein Diet 1 (Dietary supplement): 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 (Dietary supplement): 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.

+Outcome measures

Primary outcomes

Incidence of overt hepatic encephalopathy [6 months]

Secondary outcomes

Changes in nutritional status using the PG-SGA scale [6 months]
Changes in brain function using the Stroop Test (EncephalApp) [6 months]
Changes in frailty using the Liver Frailty Index [6 months]
Changes in patient-reported outcomes using Chronic Liver Disease Questionnaire [6 months]

Other outcomes

Feasibility outcomes including recruitment rate and study completion [6 months]

+Eligibility

Sex: All, ages: 18 Years to 70 Years

Inclusion Criteria:

* Diagnosis of cirrhosis
* TIPS planned for refractory ascites
* Being at least moderately malnourished

Exclusion Criteria:

* TIPS insertion for other reason than refractory ascites
* Budd Chiari Syndrome
* Complete or cavernomatous portal vein thrombosis
* Pre-TIPS recurrent or persistent overt hepatic encephalopathy
* Use of lactulose or rifaximin in the last 4 weeks
* Liver failure (MELD > 18 or Child Pugh score > 12)
* Heart failure (NYHA ≥ III or LVEF < 50%)
* Kidney failure (serum creatinine > 250µmol/L)
* Pregnancy or breastfeeding
* Previous Liver transplantation
* Unable to provide informed consent

+Locations (1)

Facility	City	Country	Status
McGill University Health Centre	Montreal, Quebec	Canada

+Investigators

Amine Benmassaoud, MD, Principal investigator, Research Institute of the McGill University Health Centre