Cirrhosis, Refractory Ascites, TIPS Insertion
Conditions
Keywords
Personalized Nutritional Intervention, Overt Hepatic Encephalopathy, Cirrhosis, Refractory Ascites, TIPS Insertion
Brief 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.
Interventions
DIETARY_SUPPLEMENTHigh 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_SUPPLEMENTHigh 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.
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Canadian Institutes of Health Research (CIHR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of overt hepatic encephalopathy | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada
Contacts
CONTACTNassim Oumansour, BSc
PRINCIPAL_INVESTIGATORAmine Benmassaoud, MD
Research Institute of the McGill University Health Centre
Outcome results
None listed