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

Primary Purpose

Frail Older Adult Syndrome, Nutrition Poor, Cardiovascular Morbidity

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ISOlution protein supplement
Placebo Supplement
Sponsored by
St. Boniface Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frail Older Adult Syndrome focused on measuring Cardiac Surgery, Protein supplementation, Pre-Frail and Frail older adults

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Boniface General HospitalRecruiting
  • Jewish General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Protein Supplementation

Placebo Supplementation

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

health-related QOL measured by the EQ-5D-3L
The EQ-5D-3L measure health related quality of life in our patient cohort
health-related QOL measured by the EQ-VAS
EQ-VAS measure health related quality of life in our patient cohort
Depression
measured by the patient health questionnaire (PHQ-9) this assessment measures the symptoms related to depression
Anxiety
measured by the cardiac anxiety questionnaire (CAQ) this assessment measures the anxiety experienced by patients with cardiovascular disease
Nutrition assessment
Nutrition is measured by the mini nutritional assessment tool
Physical Activity Accumulation
This is measured with the use of physical activity monitors call accelerometers. This will be worn for a period of 7 days after each research appointment
Composite safety endpoint of all-cause mortality, injurious fall, acute kidney injury, or readmission for related events
These parameters will be taken from medical chart reviews post cardiac surgery
Health related QOL as measured by OARS - ADL Scale
This scale measures activities of daily living
Nausea and vomiting questionnaire
This scale measures symptoms of nausea and vomiting while a patient is recovering in-hospital following cardiac surgery
Frailty
This measure will be assessed using the Modified Fried Criteria. this includes measures such as: Hand grip strength, exhaustion, nutrition, and physical activity accumulation. This assessment will return a value from 0-5 identifying the frailty of the patient at each of the time points identified

Full Information

First Posted
July 24, 2019
Last Updated
June 15, 2022
Sponsor
St. Boniface Hospital
Collaborators
Heart and Stroke Foundation of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT04038294
Brief Title
PROTein to Enhance outComes of (Pre)Frail paTients Undergoing Cardiac Surgery
Acronym
PROTECT-CS
Official Title
PROTein to Enhance outComes of (Pre)Frail paTients Undergoing Cardiac Surgery - The PROTECT-CS Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Boniface Hospital
Collaborators
Heart and Stroke Foundation of Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
To enhance recovery in vulnerable older adults (aged 60 years or older) undergoing major heart surgery. The Investigators seek to reduce the stress of heart surgery on the body by providing muscle-building nutrition supplements (with leucine-rich proteins) at key time-points during the patients' journey. Objectives of this study: Will leucine-rich protein nutrition supplementation (given in a liquid form like a protein shake) can reduce functional decline in frail older patients undergoing major heart surgery. The Investigators predict that these supplements will lead to a reduction in functional muscle loss (for example how quickly some can walk) and quicker recovery both in hospital and after going home. Will leucine-rich protein nutrition supplementation will enhance health-related quality of life of frail older adult patients after heart surgery. The Investigators predict that patients will be able to return to activities that they enjoy more quickly and experience less depression and anxiety. In a two-centre clinical trial, frail older adults (patients who are at risk of a long recovery) undergoing major heart surgeries will receive nutrition supplements up to 2 weeks prior to surgery, during post-op recovery in hospital, and for the 8 weeks following hospital discharge. Prior to surgery, all patient in the study will consume a carbohydrate supplement in order to help with nausea symptoms post surgery, glycemic control and GI function. The Investigators will ask 150 (pre)frail patients before their heart surgery to participate. Patient who are 60 years of age or older who agree to be in the study will be randomly selected (75 patients in each group) to receive the nutrition protein shakes or a placebo (a shake without the special protein). In addition to how long a patient needs to stay in hospital after their heart surgery, The Investigators will measure levels of frailty (by different tests of muscle strength), overall nutrition, health related quality of life after surgery as well as mood and anxiety at 2 and 6 months after hospital discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frail Older Adult Syndrome, Nutrition Poor, Cardiovascular Morbidity
Keywords
Cardiac Surgery, Protein supplementation, Pre-Frail and Frail older adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Protein Supplementation
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo Supplementation
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
ISOlution protein supplement
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Supplement
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Short-Form 36 physical Function (PF) score
Description
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
Time Frame
Assessed at: baseline, Day of Discharge from Hospital after cardiac surgery, 2 months post surgery and 6 months post surgery
Secondary Outcome Measure Information:
Title
health-related QOL measured by the EQ-5D-3L
Description
The EQ-5D-3L measure health related quality of life in our patient cohort
Time Frame
Assessed at: baseline, 2 months post surgery and 6 months post surgery
Title
health-related QOL measured by the EQ-VAS
Description
EQ-VAS measure health related quality of life in our patient cohort
Time Frame
Assessed at: baseline, 2 months post surgery and 6 months post surgery
Title
Depression
Description
measured by the patient health questionnaire (PHQ-9) this assessment measures the symptoms related to depression
Time Frame
Assessed at: baseline, 2 months post surgery and 6 months post surgery
Title
Anxiety
Description
measured by the cardiac anxiety questionnaire (CAQ) this assessment measures the anxiety experienced by patients with cardiovascular disease
Time Frame
Assessed at: baseline, 2 months post surgery and 6 months post surgery
Title
Nutrition assessment
Description
Nutrition is measured by the mini nutritional assessment tool
Time Frame
Assessed at: baseline, Day of Discharge from Hospital after cardiac surgery, 2 months post surgery and 6 months post surgery
Title
Physical Activity Accumulation
Description
This is measured with the use of physical activity monitors call accelerometers. This will be worn for a period of 7 days after each research appointment
Time Frame
Assessed at: baseline, 2 months post surgery and 6 months post surgery
Title
Composite safety endpoint of all-cause mortality, injurious fall, acute kidney injury, or readmission for related events
Description
These parameters will be taken from medical chart reviews post cardiac surgery
Time Frame
Parameters collected at the 2 month time point
Title
Health related QOL as measured by OARS - ADL Scale
Description
This scale measures activities of daily living
Time Frame
Assessed at: baseline, 2 months post surgery and 6 months post surgery
Title
Nausea and vomiting questionnaire
Description
This scale measures symptoms of nausea and vomiting while a patient is recovering in-hospital following cardiac surgery
Time Frame
Assessed (only 1 time point) while patient is in-hospital recovering from cardiac surgery. (i.e. 6 days after cardiac surgery)
Title
Frailty
Description
This measure will be assessed using the Modified Fried Criteria. this includes measures such as: Hand grip strength, exhaustion, nutrition, and physical activity accumulation. This assessment will return a value from 0-5 identifying the frailty of the patient at each of the time points identified
Time Frame
Assessed at: baseline, 2 months post-surgery and 6 months post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rakesh Arora, BKin,MD,PhD,
Phone
204-258-1078
Email
rarora@sbgh.mb.ca
First Name & Middle Initial & Last Name or Official Title & Degree
David Kent, BKin, MSc
Phone
204-237-2985
Email
dkent@sbgh.mb.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rakesh Arora, BKin,MD,PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H2A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rakesh Arora, MD,PhD
Phone
(204) 258-1078
Email
rarora@sbgh.mb.ca
First Name & Middle Initial & Last Name & Degree
David Kent, MSc
Phone
204-237-2985
Email
dkent@sbgh.mb.ca
First Name & Middle Initial & Last Name & Degree
Rakesh C Arora, MD, PhD
First Name & Middle Initial & Last Name & Degree
Todd A Duhamel, PhD
First Name & Middle Initial & Last Name & Degree
Navdeep Tangri, MD
First Name & Middle Initial & Last Name & Degree
Cornelia Van Ineveld, MD
First Name & Middle Initial & Last Name & Degree
Annette Schultz, PhD
First Name & Middle Initial & Last Name & Degree
Anna Chudyk, PhD
First Name & Middle Initial & Last Name & Degree
Dustin S Kehler, PhD
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Afilalo, MD
Phone
(514) 340-8232
Email
jonathan.afilalo@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Sarah Lantagne, MSc
Phone
(514) 340-8222
Ext
28692
Email
Sarah.Lantagne@ladydavis.ca
First Name & Middle Initial & Last Name & Degree
Jonathan Afilalo, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33514571
Citation
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.
Results Reference
derived

Learn more about this trial

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

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