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Dietary Supplement

Protein Supplement for Frailty in Heart Surgery Patients (PROTECT-CS Trial)

N/A

Recruiting

Led By Rakesh Arora, BKin,MD,PhD

Research Sponsored by St. Boniface Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at: baseline, 2 months post surgery and 6 months post surgery

Awards & highlights

PROTECT-CS Trial Summary

This trial will focus on a practical, real-world, treatment plan that focuses on good nutrition to prevent muscle loss and reduced frailty in vulnerable heart surgery patients.

Who is the study for?

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.Check my eligibility

What is being tested?

The study tests if the ISOlution protein supplement can help frail older adults recover better after heart surgery compared to a placebo. It aims to prevent muscle loss and reduce frailty by improving nutrition in these vulnerable patients before their operation.See study design

What are the potential side effects?

Potential side effects from the ISOlution protein supplement may include digestive discomfort such as bloating or gas due to increased protein intake. Allergic reactions could occur in those sensitive to its ingredients.

PROTECT-CS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 60 or older and scheduled for specific heart surgery.

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I am 60 or older and having surgery for heart valve issues or bypass.

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My physical function is limited, as shown by my test scores.

PROTECT-CS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at: baseline, 2 months post-surgery and 6 months post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at: baseline, 2 months post-surgery and 6 months post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at: baseline, 2 months post-surgery and 6 months post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Short-Form 36 physical Function (PF) score

Secondary outcome measures

Anxiety

Composite safety endpoint of all-cause mortality, injurious fall, acute kidney injury, or readmission for related events

Depression

+7 more

PROTECT-CS Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Protein SupplementationExperimental Treatment1 Intervention

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).

Group II: Placebo SupplementationPlacebo Group1 Intervention

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).

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Boniface HospitalLead Sponsor

51 Previous Clinical Trials

11,459 Total Patients Enrolled

Heart and Stroke Foundation of CanadaOTHER

122 Previous Clinical Trials

71,960 Total Patients Enrolled

Rakesh Arora, BKin,MD,PhDPrincipal InvestigatorUniversity of Manitoba

Media Library

ISOlution protein supplement (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04038294 — N/A

Cardiovascular Disease Research Study Groups: Protein Supplementation, Placebo Supplementation

Cardiovascular Disease Clinical Trial 2023: ISOlution protein supplement Highlights & Side Effects. Trial Name: NCT04038294 — N/A

ISOlution protein supplement (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04038294 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the purpose of this experiment?

"This clinical trial's primary objective is to observe the alteration in Short-Form 36 physical Function (PF) scores over time intervals of baseline, hospital discharge after cardiac surgery, 2 months post operation and 6 months post procedure. Secondary goals include assessing aerobic fitness through a six minute walk test as well as gauging health related quality of life by both EQ-VAS and EQ-5D-3L scales."

Answered by AI

What is the aggregate population of participants in this research project?

"Affirmative. Research posted on clinicaltrials.gov demonstrates that this undertaking, first introduced on February 12th 2020, is currently seeking participants. 150 volunteers are required from 2 different sites for inclusion in the study."

Answered by AI

Are there any current openings for this trial?

"Affirmative. Clinicaltrials.gov data indicates that this clinical trial, which was posted on February 12th of 2020, is currently recruiting patients. 150 participants need to be enrolled at two separate medical centres."

Answered by AI