Nutrition Supplementation in Cardiovascular Surgery Patients
NCT ID: NCT02961205
Last Updated: 2021-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
49 participants
INTERVENTIONAL
2017-08-01
2020-03-12
Brief Summary
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Detailed Description
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In two large tertiary hospitals in Ontario, this will be a randomized trial of a novel nutritional pathway to rapidly identify at-risk CVS patients pre-operatively, and then provide oral nutritional supplementation (ONS) during the 30 days prior to surgery, then continue supplementation throughout hospitalization until discharge. Meaningful patient-centered and economic outcomes will be examined.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Oral Nutritional Supplementation
Patients randomized to the interventional arm will receive Ensure Enlive (Abbott Nutrition), a high energy, high protein oral supplement.
Oral Nutritional Supplementation
Participants randomized to this arm will receive one bottle of Ensure Enlive 2 times per day, for 30 days prior to their cardiovascular surgery, plus continue their usual diet.
After their CVS and throughout their hospitalization they will continue to receive 2 bottles of Ensure Enlive per day, plus the standard hospital menu (3 meals per day, plus snacks or as ordered by the medical team), ending at hospital discharge.
Standard of care
Patients randomized to the control arm will continue their usual diet.
No interventions assigned to this group
Interventions
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Oral Nutritional Supplementation
Participants randomized to this arm will receive one bottle of Ensure Enlive 2 times per day, for 30 days prior to their cardiovascular surgery, plus continue their usual diet.
After their CVS and throughout their hospitalization they will continue to receive 2 bottles of Ensure Enlive per day, plus the standard hospital menu (3 meals per day, plus snacks or as ordered by the medical team), ending at hospital discharge.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Have been assessed in a pre-operative clinic
3. Have an intermediate or high risk Society of Thoracic Surgeons (STS) score
4. Malnutrition Universal Screening Tool (MUST) score of \>1.
Exclusion Criteria
2. Have advanced symptomatic angina or heart failure
3. Are designated palliative care
4. Are currently suffering from refeeding syndrome
5. Have a pre-existing medical condition that prevents oral intake of full fluids
6. Are on a fluid restricted diet
7. Are unable to walk prior to current illness
8. Have a current diagnosis of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome
9. Are pregnant or currently breastfeeding.
ALL
No
Sponsors
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Principal Investigators
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Adam Rahman, MD FRCPC
Role: PRINCIPAL_INVESTIGATOR
St. Joseph's Health Care, London ON
Locations
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LHSC-University Hospital
London, Ontario, Canada
Countries
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Other Identifiers
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INN16-003
Identifier Type: -
Identifier Source: org_study_id