Nutrition Supplementation in Cardiovascular Surgery Patients

Not Applicable

Completed

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.

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Oral Nutritional Supplementation	Oral Nutritional Supplementation	Patients randomized to the interventional arm will receive Ensure Enlive (Abbott Nutrition), a high energy, high protein oral supplement.

Primary Outcome Measures

Name	Time	Method
Recruitment	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Functional Performance	30 days post surgery date	Six Minute Walk Test will be the method of assessing physical function and therapeutic response to the intervention. Patients will be asked to walk as far as possible in six minutes, going at their own pace and resting as needed, along a marked walkway.
Nutrition Status	30 days post surgery date	The Malnutrition Universal Screening Tool (MUST) will be the method of assessment. The MUST is a five-step screening tool to identify adults, who are at-risk of malnutrition.

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