Protein supplementation to improve recovery in frail older adults undergoing heart surgery
PROTein to Enhance outComes of (Pre)Frail paTients Undergoing Cardiac Surgery - The PROTECT-CS Study
This study is testing if giving protein supplements to frail older adults before and after heart surgery can help them recover faster and feel better overall.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | St. Boniface Hospital Academic / other |
| Locations | 2 sites (Winnipeg, Manitoba and 1 other locations) |
| Trial ID | NCT04038294 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to enhance recovery in frail older adults aged 60 and above who are undergoing major heart surgery. Participants will receive leucine-rich protein supplements before and after surgery to reduce functional decline and improve health-related quality of life. The study will assess the impact of these nutritional interventions on muscle loss, recovery time, and overall well-being. The trial will take place at two centers, with a focus on patients who are at risk of prolonged recovery due to frailty.
Who should consider this trial
Good fit: Ideal candidates are frail older adults aged 60 and above who are scheduled for elective cardiac surgery and meet specific frailty criteria.
Not a fit: Patients who are severely frail or terminally ill, as well as those with decompensated symptoms, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes and quality of life for frail older adults after heart surgery.
How similar studies have performed: Previous studies have indicated that nutritional supplementation can improve recovery in frail populations, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. Patients with a Clinical Frailty Score (CFS) from 3 (Managing Well) to 7 (severely frail), 3. Patients with a Short Physical Performance Battery (SPPB) score of 9 or less, or an SF-36 (PF) score of \<= 60 4. Patients with an estimated wait time for elective cardiac surgery of 1 week or longer 5. Inpatients with an estimated wait time for non-emergent cardiac surgery of 2 days or longer from hospital admission Exclusion Criteria: 1. Decompensated or non-ambulatory class IV symptoms of angina, dyspnea, claudication 2. 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. 3. Creatinine clearance \<30 mL/min/1.83 m2 4. Cirrhosis (Child-Pugh Class B or greater) 5. Allergy to milk proteins or other ingredients in the supplement 6. Inability to safely ingest beverage by mouth 7. Significant cognitive impairment (MoCA Score \< 16) 8. An inability to speak/read in English or French 9. Non-emergent or emergent surgery less than 2 days from hospital admission
Where this trial is running
Winnipeg, Manitoba and 1 other locations
- St. Boniface General Hospital — Winnipeg, Manitoba, Canada (Recruiting)
- Jewish General Hospital — Montréal, Quebec, Canada (Not_yet_recruiting)
Study contacts
- Principal investigator: Rakesh Arora, BKin,MD,PhD — University of Manitoba
- Study coordinator: Rakesh Arora, BKin,MD,PhD,
- Email: rarora@sbgh.mb.ca
- Phone: 204-258-1078
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.