Protein Supplement for Frailty in Heart Surgery Patients
(PROTECT-CS Trial)
Trial Summary
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment ISOlution protein supplement for frailty in heart surgery patients?
Is the protein supplement safe for humans?
How is the ISOlution protein supplement treatment different from other treatments for frailty in heart surgery patients?
What is the purpose of this trial?
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.
Research Team
Rakesh Arora, BKin,MD,PhD
Principal Investigator
University of Manitoba
Eligibility Criteria
This trial is for patients aged 60 or older who are frail and waiting for non-emergency heart surgery. They must be able to drink by mouth, speak/read English or French, have a Clinical Frailty Score of 3-6, and an SPPB score ≤9 or SF-36 (PF) score ≤60. Excluded are those with severe cognitive impairment, kidney issues, liver cirrhosis, milk protein allergies, or very severe symptoms.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-surgery Nutrition
Participants receive carbohydrate supplements to help with nausea symptoms, glycemic control, and GI function, and leucine-rich protein supplements for up to 2 weeks prior to surgery.
Post-operative Recovery
Participants receive leucine-rich protein supplements during post-operative recovery in the hospital.
Post-discharge Nutrition
Participants continue to receive leucine-rich protein supplements for 8 weeks following hospital discharge.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 2 and 6 months post-surgery.
Treatment Details
Interventions
- ISOlution protein supplement
- Placebo Supplement
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Boniface Hospital
Lead Sponsor
Heart and Stroke Foundation of Canada
Collaborator