Nutrition Supplementation in Cardiovascular Surgery Patients (NutriSuP-CVS)

Lawson Health Research Institute

Status: Completed

Conditions: Malnutrition

Treatments: Dietary Supplement: Oral Nutritional Supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT02961205

INN16-003

Details and patient eligibility

About

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.

Full description

Cardiovascular surgery (CVS) is a resource intensive modality in the treatment of coronary artery disease and valvular heart disease. CVS patients who are malnourished experience increased duration of cardiopulmonary bypass, post-operative infections, impaired wound healing, muscle wasting, longer lengths of intensive care unit (ICU) and hospital stay, higher readmission rates, higher treatment costs and marked increases in mortality. Despite the devastating effects of malnutrition in these patients, physicians and health care practitioners are poor in respect to identification, monitoring and treatment of malnutrition.

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.

Enrollment: 49 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Require cardiovascular surgery
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

1. Require urgent/emergent cardiovascular surgery
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Oral Nutritional Supplementation

Experimental group

Description:

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

Treatment:

Dietary Supplement: Oral Nutritional Supplementation

Standard of care

No Intervention group

Description:

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