PROTein to Enhance outComes of (Pre)Frail paTients Undergoing Cardiac Surgery (PROTECT-CS)
Frail Older Adult Syndrome, Nutrition Poor, Cardiovascular Morbidity
About this trial
This is an interventional treatment trial for Frail Older Adult Syndrome focused on measuring Cardiac Surgery, Protein supplementation, Pre-Frail and Frail older adults
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Decompensated or non-ambulatory class IV symptoms of angina, dyspnea, claudication
- Patients with a Clinical Frailty Score (CFS) of 7 or greater (Severely frail to terminally ill); this will exclude less than 1% of the population on the elective cardiac surgery waitlist.
- Creatinine clearance <30 mL/min/1.83 m2
- Cirrhosis (Child-Pugh Class B or greater)
- Allergy to milk proteins or other ingredients in the supplement
- Inability to safely ingest beverage by mouth
- Significant cognitive impairment (MoCA Score < 16)
- An inability to speak/read in English or French
- Non-emergent or emergent surgery less than 2 days from hospital admission
Sites / Locations
- St. Boniface General HospitalRecruiting
- Jewish General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Protein Supplementation
Placebo 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).
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).