Clinical trial NCT02961205: Nutrition Supplementation in Cardiovascular Surgery Patients
Official title: Nutrition Supplementation in Cardiovascular Surgery Patients-A Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2016-11-10
Enrollment: 49
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment
timeFrame: 1 year
Secondary outcomes:
measure: Nutrition Status
timeFrame: 30 days post surgery date
measure: Functional Performance
timeFrame: 30 days post surgery date
Other outcomes:
Locations:
city: London
country: Canada
facility: LHSC-University Hospital
state: Ontario
Study officials:
affiliation: St. Joseph's Health Care, London ON
name: Adam Rahman, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: