Clinical trial NCT04038294: PROTein to Enhance outComes of (Pre)Frail paTients Undergoing Cardiac Surgery
Official title: PROTein to Enhance outComes of (Pre)Frail paTients Undergoing Cardiac Surgery - The PROTECT-CS Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frail Older Adult Syndrome
Nutrition Poor
Cardiovascular Morbidity
Keywords: Cardiac Surgery
Protein supplementation
Pre-Frail and Frail older adults
Lead sponsor: St. Boniface Hospital
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
First posted: 2019-07-30
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. 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.
2. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Short-Form 36 physical Function (PF) score
timeFrame: Assessed at: baseline, Day of Discharge from Hospital after cardiac surgery, 2 months post surgery and 6 months post surgery
Secondary outcomes:
measure: health-related QOL measured by the EQ-5D-3L
timeFrame: Assessed at: baseline, 2 months post surgery and 6 months post surgery
measure: health-related QOL measured by the EQ-VAS
timeFrame: Assessed at: baseline, 2 months post surgery and 6 months post surgery
measure: Depression
timeFrame: Assessed at: baseline, 2 months post surgery and 6 months post surgery
measure: Anxiety
timeFrame: Assessed at: baseline, 2 months post surgery and 6 months post surgery
measure: Nutrition assessment
timeFrame: Assessed at: baseline, Day of Discharge from Hospital after cardiac surgery, 2 months post surgery and 6 months post surgery
measure: Physical Activity Accumulation
timeFrame: Assessed at: baseline, 2 months post surgery and 6 months post surgery
measure: Composite safety endpoint of all-cause mortality, injurious fall, acute kidney injury, or readmission for related events
timeFrame: Parameters collected at the 2 month time point
measure: Health related QOL as measured by OARS - ADL Scale
timeFrame: Assessed at: baseline, 2 months post surgery and 6 months post surgery
measure: Nausea and vomiting questionnaire
timeFrame: Assessed (only 1 time point) while patient is in-hospital recovering from cardiac surgery. (i.e. 6 days after cardiac surgery)
measure: Frailty
timeFrame: Assessed at: baseline, 2 months post-surgery and 6 months post-surgery
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: University of Manitoba
name: Rakesh Arora, BKin,MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.