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

NCT04038294 | Unknown DMC

• 1 other identifier: G-19-0024269
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Cardiac Surgery; Protein supplementation; Pre-Frail and Frail older adults

Outcome Measures

Primary Outcomes (1)

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

  The SF-36 PF assessment captures the physical functioning of participants. It has been moderately correlated with the SPPB and can be used interchangeably if the SPPB is not able to be completed by a patient

  Assessed at: baseline, Day of Discharge from Hospital after cardiac surgery, 2 months post surgery and 6 months post surgery

Secondary Outcomes (10)

• health-related QOL measured by the EQ-5D-3L

  Assessed at: baseline, 2 months post surgery and 6 months post surgery

• health-related QOL measured by the EQ-VAS

  Assessed at: baseline, 2 months post surgery and 6 months post surgery

• Depression

  Assessed at: baseline, 2 months post surgery and 6 months post surgery

• Anxiety

  Assessed at: baseline, 2 months post surgery and 6 months post surgery

• Nutrition assessment

  Assessed at: baseline, Day of Discharge from Hospital after cardiac surgery, 2 months post surgery and 6 months post surgery

Study Arms (2)

Protein Supplementation

EXPERIMENTAL

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).

Dietary Supplement: ISOlution protein supplement

Placebo Supplementation

PLACEBO COMPARATOR

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).

Dietary Supplement: Placebo Supplement

Interventions

ISOlution protein supplement DIETARY_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.

Protein Supplementation

Placebo Supplement DIETARY_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

Placebo Supplementation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients with a Clinical Frailty Score (CFS) from 3 (Managing Well) to 7 (severely frail),
• Patients with a Short Physical Performance Battery (SPPB) score of 9 or less, or an SF-36 (PF) score of \<= 60
• Patients with an estimated wait time for elective cardiac surgery of 1 week or longer
• Inpatients with an estimated wait time for non-emergent cardiac surgery of 2 days or longer from hospital admission

You may not qualify if:

• Decompensated or non-ambulatory class IV symptoms of angina, dyspnea, claudication
• 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.
• Creatinine clearance \<30 mL/min/1.83 m2
• Cirrhosis (Child-Pugh Class B or greater)
• Allergy to milk proteins or other ingredients in the supplement
• Inability to safely ingest beverage by mouth
• Significant cognitive impairment (MoCA Score \< 16)
• An inability to speak/read in English or French
• Non-emergent or emergent surgery less than 2 days from hospital admission

Sponsors & Collaborators

• St. Boniface Hospital: lead
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (2)

St. Boniface General Hospital

Winnipeg, Manitoba, R2H2A6, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

NOT YET RECRUITING

Related Publications (1)

• Rose AV, Duhamel T, Hyde C, Kent DE, Afilalo J, Schultz ASH, Chudyk A, Kehler DS, Dave M, Arora RC. Randomised controlled trial protocol for the PROTECT-CS Study: PROTein to Enhance outComes of (pre)frail paTients undergoing Cardiac Surgery. BMJ Open. 2021 Jan 29;11(1):e037240. doi: 10.1136/bmjopen-2020-037240.

  PMID: 33514571 DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Rakesh Arora, BKin,MD,PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rakesh Arora, BKin,MD,PhD,

CONTACT

204-258-1078; rarora@sbgh.mb.ca

David Kent, BKin, MSc

CONTACT

204-237-2985; dkent@sbgh.mb.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: the patient/participants, the treating physician and the outcomes assessor (research assistant will be blinded to the arm of the participant. Only the Mani study coordinator will have known information of arm population
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section head Cardiac Surgery

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 30, 2019
• Study Start: February 12, 2020
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)