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Search / Trial NCT04038294

PROTein to Enhance outComes of (Pre)Frail paTients Undergoing Cardiac Surgery

Launched by ST. BONIFACE HOSPITAL · Jul 26, 2019

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Cardiac Surgery Protein Supplementation Pre Frail And Frail Older Adults

ClinConnect Summary

The clinical trial titled "PROTein to Enhance outComes of (Pre)Frail paTients Undergoing Cardiac Surgery" is studying how improving nutrition can help older patients who are frail recover better after heart surgery. Many older adults undergoing heart surgery face challenges like longer recovery times, loss of independence, and a higher risk of complications. This study focuses on patients aged 60 and older who are scheduled for specific heart surgeries and have been identified as frail based on a simple scoring system.

To be eligible for the trial, participants should have a certain level of frailty and a waiting period for surgery. Those who join the study will receive a nutrition plan designed to help prevent muscle loss and support their recovery. This initiative is crucial as it aims to address the lack of nutritional support for frail patients before their surgery. By participating, patients may not only improve their chances of a smoother recovery but also enhance their overall quality of life after surgery.

Gender

ALL

Eligibility 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

About St. Boniface Hospital

St. Boniface Hospital is a leading healthcare institution committed to advancing medical research and improving patient care through innovative clinical trials. As a recognized sponsor of clinical studies, the hospital leverages its state-of-the-art facilities and a multidisciplinary team of healthcare professionals to conduct rigorous research across various therapeutic areas. With a focus on translating scientific findings into practical applications, St. Boniface Hospital collaborates with academic institutions and industry partners to enhance treatment options and contribute to the broader medical community. Its dedication to ethical standards and patient safety ensures that all trials are conducted with the highest level of integrity and care.

Locations

Winnipeg, Manitoba, Canada

Montréal, Quebec, Canada

Patients applied

0 patients applied

Trial Officials

Rakesh Arora, BKin,MD,PhD

Principal Investigator

University of Manitoba

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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