Nutrition Supplementation in Cardiovascular Surgery Patients

NCT02961205 | Completed

• 1 other identifier: INN16-003
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled pilot study evaluates the use of oral nutritional supplementation in nutritionally at-risk cardiovascular surgery patients. The oral nutrition supplement is given for 30 days prior to surgery, continuing throughout their surgical hospitalization and ends at hospital discharge. Half of the participants will receive the oral nutritional supplement and the other half will not.

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

• Recruitment

  This pilot study will be considered as successfully demonstrating feasibility of recruitment if 60 participants are recruited over 12 months. The overarching objective of this pilot study is to prove feasibility of recruitment and of the protocol in order to continue to a large phase 3 trial.

  1 year

Secondary Outcomes (2)

• Nutrition Status

  30 days post surgery date

• Functional Performance

  30 days post surgery date

Study Arms (2)

Oral Nutritional Supplementation

EXPERIMENTAL

Patients randomized to the interventional arm will receive Ensure Enlive (Abbott Nutrition), a high energy, high protein oral supplement.

Dietary Supplement: Oral Nutritional Supplementation

Standard of care

NO INTERVENTION

Patients randomized to the control arm will continue their usual diet.

Interventions

Oral Nutritional Supplementation DIETARY_SUPPLEMENT

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.

Also known as: Ensure Enlive

Oral Nutritional Supplementation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Require cardiovascular surgery
• Have been assessed in a pre-operative clinic
• Have an intermediate or high risk Society of Thoracic Surgeons (STS) score
• Malnutrition Universal Screening Tool (MUST) score of \>1.

You may not qualify if:

• Require urgent/emergent cardiovascular surgery
• Have advanced symptomatic angina or heart failure
• Are designated palliative care
• Are currently suffering from refeeding syndrome
• Have a pre-existing medical condition that prevents oral intake of full fluids
• Are on a fluid restricted diet
• Are unable to walk prior to current illness
• Have a current diagnosis of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome
• Are pregnant or currently breastfeeding.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

LHSC-University Hospital

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Adam Rahman, MD FRCPC

  St. Joseph's Health Care, London ON

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2016
• First Posted: November 10, 2016
• Study Start: August 1, 2017
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)