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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrition Intervention 1 | Experimental | As participants are blinded, description of the arm 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. |
|
| Nutrition Intervention 2 | Active Comparator | As participants are blinded, description of the arm 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of overt hepatic encephalopathy | 6 months |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility outcomes including recruitment rate and study completion | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nassim Oumansour, BSc | Contact | 514-934-1934 | 34868 | nassim.oumansour@rimuhc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Amine Benmassaoud, MD | Research Institute of the McGill University Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Centre | Montreal | Quebec | Canada |
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|
| 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. |
|
| 6 months |
| Changes in patient-reported outcomes using Chronic Liver Disease Questionnaire | 6 months |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D001201 | Ascites |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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