SAGE-Heart : Senior Assessment fraGility and Post-opErative QALYs 1 Year After Emergency HEART Surgery for Patients Aged 75 and Older
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 265
- 试验地点
- 1
- 主要终点
- Quality-Adjusted Life Years (QALYs) according to preoperative frailty status
研究概览
简要总结
The hypothesis is that the preoperative Clinical Frailty Score (CFS) is a predictive factor for a loss in quality-adjusted life years (QALYs) one year after emergency cardiac surgery under cardiopulmonary bypass (CPB) in patients aged 75 years and older.
详细描述
The advancement of structural cardiology, particularly with percutaneous valve interventions, offers new treatment options without the need for cardiopulmonary bypass (CPB). Despite an increase in the use of these techniques, some studies highlight a notable rise in CPB usage in patients aged 80 and over, from 13.8% in 2013 to 20.5% in 2022. In France, the population aged 85 and above is expected to triple by 2050, meaning more elderly patients will be eligible for CPB cardiac surgery. Several global studies have examined the outcomes of older individuals undergoing CPB cardiac surgery. While EuroSCORE II and STS scores are effective in predicting short-term mortality, they lack accuracy in predicting long-term mortality, particularly in frail patients, and do not assess quality of life. New tools to evaluate frailty, such as the Clinical Frailty Scale (CFS), are now used in preoperative assessments for planned cardiac interventions. Identifying frail elderly patients early is crucial for improving patient and family information on care plans, especially in high-risk surgeries. Even in emergencies, patients must remain involved in their health decisions, and multidisciplinary collaboration is vital for improving postoperative recovery and quality of life.
Data will be collected :
- Preoperative: During the anesthesia consultation: Calculation of the CFS (frailty assessment = CFS ≥ 4) EuroQoL 5D-5L (quality of life, with the index calculated with the French value set of the EuroQol), and routine care (renal function: urea, creatinine, albumin levels).
- Postoperative (ICU and hospital): Collection of complication incidence, mortality (all causes and LATA-related).
- Follow-up (by phone at 3, 6, and 12 months): CFS and EuroQoL scores, prevalence of chronic pain and analgesic use, dialysis dependency, accommodation status, readmission rates, and death date if applicable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 75 years who are affiliated with or beneficiaries of a social security scheme and undergoing emergency cardiac surgery under cardiopulmonary bypass, either immediate or urgent (relative) :
- •Immediate emergency surgery: intervention performed before the start of the next working day following the decision to operate,
- •Urgent (relative) emergency surgery: patients not admitted electively for surgery but requiring an intervention during the current hospital stay for medical reasons, and who cannot be discharged without undergoing a definitive procedure
排除标准
- •Patients requiring preoperative cardiopulmonary resuscitation
- •Scheduled (elective) surgery
- •Lack of informed consent
- •Impaired consciousness at the time of inclusion (defined by a Glasgow Coma Scale score < 15)
- •Individuals under legal guardianship or judicial protection
- •Individuals participating in another interventional research protocol
结局指标
主要结局
Quality-Adjusted Life Years (QALYs) according to preoperative frailty status
时间窗: Month 12
QALYs over the 12-month follow-up will be estimated from EQ-5D-5L utility scores collected at baseline, Month 3, Month 6, and Month 12 together with survival data, and compared between participants with preoperative frailty (Clinical Frailty Scale ≥4) and those without frailty (Clinical Frailty Scale \<4), with adjustment for EuroSCORE II.
次要结局
- Postoperative complications(From surgery through,Day 28)
- All-cause mortality(Through Month 12)
- EQ-5D-5L Utility Index(Baseline, Month 3, Month 6, and Month 12)
- Dialysis dependence(Month 3, Month 6, and Month 12)
- Length of intensive care unit stay(From ICU admission to ICU discharge (assessed up to Day 28))
- Length of hospital stay(From surgery to hospital discharge)
- Hospital readmissions(Month 3, Month 6, and Month 12)
- Chronic postoperative pain(Month 3, Month 6, and Month 12)
- Analgesic consumption(Month 3, Month 6, and Month 12)
- Living situation(Month 3, Month 6, and Month 12)
- EQ-5D-5L visual analogue scale (EQ VAS)(Baseline, Month 3, Month 6, and Month 12)