NCT02961205

Nutrition Supplementation in Cardiovascular Surgery Patients

Nutrition Supplementation in Cardiovascular Surgery Patients-A Randomized Controlled Pilot Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Malnutrition

Interventions

Type	Name	Description
DIETARY_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.

Timeline

• Start date: 2017-08-01
• Primary completion: 2020-03-12
• Completion: 2020-03-12
• First posted: 2016-11-10
• Last updated: 2021-10-28

Locations

1 site across 1 country: Canada