Nutritional Intervention for Ascites

(SUPPRESS-HE Trial)

NO
Overseen ByNassim Oumansour, BSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

AB

Amine Benmassaoud, MD

Principal Investigator

Research Institute of the McGill University Health Centre

Are You a Good Fit for This Trial?

This trial is for adults with liver cirrhosis who are moderately malnourished and scheduled to have a TIPS procedure due to fluid buildup (ascites) that hasn't responded to other treatments.

Inclusion Criteria

I have been diagnosed with cirrhosis.
I am scheduled for a TIPS procedure because of ascites that won't go away.
* Being at least moderately malnourished

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a personalized nutritional intervention to prevent overt hepatic encephalopathy

12 weeks
Regular visits with a dietitian

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • High Energy and High Protein Diet 1
  • High Energy and High Protein Diet 2

Trial Overview

The study compares two types of high-energy, high-protein diets given after the TIPS procedure to see which one better prevents serious brain-related complications called hepatic encephalopathy.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Nutrition Intervention 1Experimental Treatment1 Intervention
Group II: Nutrition Intervention 2Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials
476
Recruited
170,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+