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

ConditionsCirrhosisRefractory AscitesTIPS Insertion
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of cirrhosis

TIPS planned for refractory ascites

Being at least moderately malnourished

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Nutrition Intervention 1Experimental treatment 1 intervention
Group B: Nutrition Intervention 2Active comparator 1 intervention

Trial outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: