Frail Older Adult SyndromePROTECT-CSNCT04038294
PROTein to Enhance outComes of (Pre)Frail paTients Undergoing Cardiac Surgery
A study testing ISOlution protein supplement in people with Frail Older Adult Syndrome and Nutrition Poor, run by St. Boniface Hospital at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frail Older Adult Syndrome, Nutrition Poor, Cardiovascular Morbidity
- What is being tested?
- ISOlution protein supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesCanada
- Study dates
- 12 Feb 2020to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Not yet recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Jonathan Afilalo, MD, (514) 340-8232, jonathan.afilalo@mcgill.ca
Sarah Lantagne, MSc, (514) 340-8222 ext. 28692, Sarah.Lantagne@ladydavis.ca
- Recruiting
St. Boniface General Hospital
Winnipeg, Manitoba, R2H2A6
Rakesh Arora, MD,PhD, (204) 258-1078, rarora@sbgh.mb.ca
David Kent, MSc, 204-237-2985, dkent@sbgh.mb.ca
About this study
Official title: PROTein to Enhance outComes of (Pre)Frail paTients Undergoing Cardiac Surgery - The PROTECT-CS Study
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.
Read the 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.
- Being tested
- ISOlution protein supplement, Placebo Supplement
- Keywords
- Cardiac Surgery, Protein supplementation, Pre-Frail and Frail older adults
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISOlution protein supplementDietary 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.
Placebo SupplementDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Dietary Supplement: Placebo Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
The EQ-5D-3L measure health related quality of life in our patient cohort
Measured: Assessed at: baseline, 2 months post surgery and 6 months post surgery
health-related QOL measured by the EQ-VAS
EQ-VAS measure health related quality of life in our patient cohort
Measured: Assessed at: baseline, 2 months post surgery and 6 months post surgery
Depression
measured by the patient health questionnaire (PHQ-9) this assessment measures the symptoms related to depression
Measured: Assessed at: baseline, 2 months post surgery and 6 months post surgery
Anxiety
measured by the cardiac anxiety questionnaire (CAQ) this assessment measures the anxiety experienced by patients with cardiovascular disease
Measured: Assessed at: baseline, 2 months post surgery and 6 months post surgery
Nutrition assessment
Nutrition is measured by the mini nutritional assessment tool
Measured: Assessed at: baseline, Day of Discharge from Hospital after cardiac surgery, 2 months post surgery and 6 months post surgery
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
Measured: Assessed at: baseline, 2 months post surgery and 6 months post surgery
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
Measured: Parameters collected at the 2 month time point
Health related QOL as measured by OARS - ADL Scale
This scale measures activities of daily living
Measured: Assessed at: baseline, 2 months post surgery and 6 months post surgery
Nausea and vomiting questionnaire
This scale measures symptoms of nausea and vomiting while a patient is recovering in-hospital following cardiac surgery
Measured: Assessed (only 1 time point) while patient is in-hospital recovering from cardiac surgery. (i.e. 6 days after 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
Measured: Assessed at: baseline, 2 months post-surgery and 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start12 Feb 2020
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frail Older Adult SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Boniface Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Responsible party
- Principal investigator, Dr. Rakesh C. Arora, St. Boniface Hospital
- Investigators
- Rakesh Arora, BKin,MD,PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038294
- Sponsor's protocol ID
- G-19-0024269
- Acronym
- PROTECT-CS
- Status last verified
- Dec 2023
- First submitted
- 24 Jul 2019
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33514571
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROTein to Enhance outComes of (Pre)Frail paTients Undergoing Cardiac Surgery - The PROTECT-CS Study
- ClinicalTrials.gov ID
- NCT04038294
- Acronym / sponsor ID
- PROTECT-CS / G-19-0024269
- Keywords
- Cardiac Surgery, Protein supplementation, Pre-Frail and Frail older adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- St. Boniface HospitalUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein Supplementation | Experimental | Dietary Supplement: ISOlution protein supplementThe 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). |
| Placebo Supplementation | Placebo comparator | Dietary Supplement: Placebo SupplementEnrolled 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). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISOlution protein supplementEXPERIMENTAL 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 | Protein Supplementation |
| Placebo SupplementPLACEBO 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 | Dietary supplement | Placebo Supplementation |
Primary outcome
Change in Short-Form 36 physical Function (PF) score
Time frame: Assessed at: baseline, Day of Discharge from Hospital after cardiac surgery, 2 months post surgery and 6 months post surgery
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
10 secondary outcomes
health-related QOL measured by the EQ-5D-3L
Time frame: Assessed at: baseline, 2 months post surgery and 6 months post surgery
health-related QOL measured by the EQ-VAS
Time frame: Assessed at: baseline, 2 months post surgery and 6 months post surgery
Depression
Time frame: Assessed at: baseline, 2 months post surgery and 6 months post surgery
Anxiety
Time frame: Assessed at: baseline, 2 months post surgery and 6 months post surgery
Nutrition assessment
Time frame: Assessed at: baseline, Day of Discharge from Hospital after cardiac surgery, 2 months post surgery and 6 months post surgery
Physical Activity Accumulation
Time frame: Assessed at: baseline, 2 months post surgery and 6 months post surgery
Composite safety endpoint of all-cause mortality, injurious fall, acute kidney injury, or readmission for related events
Time frame: Parameters collected at the 2 month time point
Health related QOL as measured by OARS - ADL Scale
Time frame: Assessed at: baseline, 2 months post surgery and 6 months post surgery
Nausea and vomiting questionnaire
Time frame: Assessed (only 1 time point) while patient is in-hospital recovering from cardiac surgery. (i.e. 6 days after cardiac surgery)
Frailty
Time frame: Assessed at: baseline, 2 months post-surgery and 6 months post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Derived from this study: PubMed 33514571Rose 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rakesh Arora, BKin,MD,PhD principal investigator
University of Manitoba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ISOlution protein supplement in people with Frail Older Adult Syndrome and Nutrition Poor, run by St. Boniface Hospital at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rakesh Arora, BKin,MD,PhD, (204-258-1078, rarora@sbgh.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Short-Form 36 physical Function (PF) score (time frame: Assessed at: baseline, Day of Discharge from Hospital after cardiac surgery, 2 months post surgery and 6 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04038294, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.