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

NCT04038294 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-12-18

No results posted yet for this study

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 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.

Conditions

  • Frail Older Adult Syndrome
  • Nutrition Poor
  • Cardiovascular Morbidity

Interventions

DIETARY_SUPPLEMENT

ISOlution protein supplement

EXPERIMENTAL ARM: Protein supplement 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.

DIETARY_SUPPLEMENT

Placebo Supplement

PLACEBO COMPARATOR ARM: Placebo supplement 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

Sponsors & Collaborators

  • Heart and Stroke Foundation of Canada

    collaborator OTHER

  • St. Boniface Hospital

    lead OTHER

Principal Investigators

  • Rakesh Arora, BKin,MD,PhD · University of Manitoba

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-12
Primary Completion
2024-12-30
Completion
2025-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04038294 on ClinicalTrials.gov