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NCT Number: NCT07634237

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

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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Key information

Conditions

Cirrhosis Ascites Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Refractory Ascites TIPS Insertion

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence of overt hepatic encephalopathy

    Time frame: 6 months

Secondary outcomes

  1. Changes in nutritional status using the PG-SGA scale

    Time frame: 6 months

  2. Changes in brain function using the Stroop Test (EncephalApp)

    Time frame: 6 months

  3. Changes in frailty using the Liver Frailty Index

    Time frame: 6 months

  4. Changes in patient-reported outcomes using Chronic Liver Disease Questionnaire

    Time frame: 6 months

Other outcomes

  1. Feasibility outcomes including recruitment rate and study completion

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Nassim Oumansour, BSc

CONTACT

[email protected]

514-934-1934 ext. 34868

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study 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)

Acronym: SUPPRESS-HE

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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