PROTein to Enhance outComes of (Pre)Frail paTients Undergoing Cardiac Surgery - The PROTECT-CS Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Heart disease in an aging population has resulted in heart surgery being offered to older and more frail patients. Frail patients which make up more than 50% of patients currently undergoing heart surgery are vulnerable to having long-recovery times after surgery, greater loss of independence (i.e. being admitted to a nursing home), experience more depression and anxiety, and have a worse quality of life. In fact, nearly 10% of frail, older adult patients die within 30 days after their heart surgery. The Investigators previous study found that weight-loss and poor muscle strength (i.e. weakness) of frail patients can lead to a worse recovery after heart surgery. Furthermore, inadequate nutrition (aka. malnutrition which is defined as an unintentional, nutritional intake imbalance (not necessarily a decreased intake) before an operation can lead to a vicious cycle of muscle loss causing more frailty, a desire to eat less leading to more muscle loss and increased frailty. At present there is no process to address this important issue in older adults undergoing heart surgery. The Investigators propose to study a practical, real-world, treatment plan that focuses on good nutrition to prevent muscle loss and reduced frailty in vulnerable heart surgery patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• Patients aged 60 years of age or older, undergoing elective isolated CABG, aortic valve repair or replacement for moderate aortic stenosis or severe regurgitation, mitral valve repair or replacement for moderate stenosis or severe regurgitation or combined CABG/valve procedures.

• Patients with a Clinical Frailty Score (CFS) from 3 (Managing Well) to 7 (severely frail),

• Patients with a Short Physical Performance Battery (SPPB) score of 9 or less, or an SF-36 (PF) score of \<= 60

• Patients with an estimated wait time for elective cardiac surgery of 1 week or longer

• Inpatients with an estimated wait time for non-emergent cardiac surgery of 2 days or longer from hospital admission

Locations
Other Locations
Canada
Jewish General Hospital
NOT_YET_RECRUITING
Montreal
St. Boniface General Hospital
RECRUITING
Winnipeg
Contact Information
Primary
Rakesh Arora, BKin,MD,PhD,
rarora@sbgh.mb.ca
204-258-1078
Backup
David Kent, BKin, MSc
dkent@sbgh.mb.ca
204-237-2985
Time Frame
Start Date: 2020-02-12
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 150
Treatments
Experimental: Protein Supplementation
The intended intervention consists of a leucine-rich protein-caloric supplement provided by the Enhanced Medical Nutrition®. The product contains 25 g protein and 3 g Leucine per serving (total caloric value: 160 Kcal.) to be re-constituted and consumed twice daily for a minimum of 2 weeks pre-procedure, twice daily during post-operative recovery and 2 times daily for 8 weeks after the patient is discharged home (Appendix A).
Placebo_comparator: Placebo Supplementation
Enrolled patients allocated to the control group will receive the same supplementation schedule as well as compliance verification; however, they will receive a placebo product with no supplemented protein (no nutritional benefit).
Related Therapeutic Areas
Sponsors
Leads: St. Boniface Hospital
Collaborators: Heart and Stroke Foundation of Canada

This content was sourced from clinicaltrials.gov