Personalized Nutritional Intervention in Patients Undergoing TIPS Insertion for Refractory Ascites to Prevent Overt Hepatic Encephalopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High Energy and High Protein Diet 1, High Energy and High Protein Diet 2.
- Who it may be relevant to
- Registry conditions: Cirrhosis, Refractory Ascites, TIPS Insertion. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Interventions
- Dietary supplement 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. - Dietary supplement 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.
Primary outcome measures
- Incidence of overt hepatic encephalopathy [Time frame: 6 months]
Secondary outcome measures (4)
- Changes in nutritional status using the PG-SGA scale [Time frame: 6 months]
- Changes in brain function using the Stroop Test (EncephalApp) [Time frame: 6 months]
- Changes in frailty using the Liver Frailty Index [Time frame: 6 months]
- Changes in patient-reported outcomes using Chronic Liver Disease Questionnaire [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- McGill University Health Centre — Montreal
Identifiers
NCT: NCT07634237 · MP-37-2025-10963