PROTein to Enhance outComes of (Pre)Frail paTients Undergoing Cardiac Surgery - The PROTECT-CS Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Change in Short-Form 36 physical Function (PF) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Short-Form 36 physical Function (PF) score
时间窗: 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
次要结局
- health-related QOL measured by the EQ-VAS(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(Parameters collected at the 2 month time point)
- Anxiety(Assessed at: baseline, 2 months post surgery and 6 months post surgery)
- Physical Activity Accumulation(Assessed at: baseline, 2 months post surgery and 6 months post surgery)
- Health related QOL as measured by OARS - ADL Scale(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)
- health-related QOL measured by the EQ-5D-3L(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)
- Nausea and vomiting questionnaire(Assessed (only 1 time point) while patient is in-hospital recovering from cardiac surgery. (i.e. 6 days after cardiac surgery))
- Frailty(Assessed at: baseline, 2 months post-surgery and 6 months post-surgery)
研究者
Dr. Rakesh C. Arora
Section head Cardiac Surgery
St. Boniface Hospital