Status:
UNKNOWN
PROTein to Enhance outComes of (Pre)Frail paTients Undergoing Cardiac Surgery
Lead Sponsor:
St. Boniface Hospital
Collaborating Sponsors:
Heart and Stroke Foundation of Canada
Conditions:
Frail Older Adult Syndrome
Nutrition Poor
Eligibility:
All Genders
60+ years
Phase:
NA
Brief 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 sur...
Detailed Description
To enhance recovery in vulnerable older adults (aged 60 years or older) undergoing major heart surgery. The Investigators seek to reduce the stress of heart surgery on the body by providing muscle-bui...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04038294
Start Date
February 12 2020
End Date
June 30 2025
Last Update
December 18 2023
Active Locations (2)
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1
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H2A6
2
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2