An interventional study of ISOlution protein supplement and Placebo Supplement in Frail Older Adult Syndrome, Nutrition Poor and Cardiovascular Morbidity, sponsored by St. Boniface Hospital. Recruiting at 2 sites in Canada. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2023-12-18.
Sponsored by St. Boniface Hospital · Not applicable, Interventional, and Treatment
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.
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:
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.
1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.
This study's planned enrollment of 150 is above the median of 118 across 843 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →St. Boniface Hospital is the lead sponsor of 32 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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 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
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
Time frame: Assessed at: baseline, Day of Discharge from Hospital after cardiac surgery, 2 months post surgery and 6 months post surgery
health-related QOL measured by the EQ-5D-3L
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
health-related QOL measured by the EQ-VAS
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
Depression
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
Anxiety
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
Nutrition assessment
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
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
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
These parameters will be taken from medical chart reviews post cardiac surgery
Time frame: Parameters collected at the 2 month time point
Health related QOL as measured by OARS - ADL Scale
This scale measures activities of daily living
Time frame: 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
Time frame: 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
Time frame: Assessed at: baseline, 2 months post-surgery and 6 months post-surgery
Plan to share: No
Started Feb 2020 (actual). Primary completion is estimated for Dec 2024, 58 months after the start.
Of 392 non-industry interventional studies with no phase under Malnutrition, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's planned 58 months is above that.
Counting every sponsor, half of 418 studies reached it within 22 months; a quarter within 11 and three quarters within 37.
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