Cardiac Surgery as a Means of Reversing Frailty - The CURE-Frailty Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Postoperative Level of Frailty
研究概览
简要总结
Frailty is a multifactorial condition associated with older age, which leads to increased vulnerability to external stressors, such as infections or surgical procedures. Key features of frailty are unintentional weight loss, reduced strength and physical activity as well as the feeling of exhaustion.
When selecting patients for surgery, frailty can play an important part in resource planning and prognostication. Multiple studies have shown frailty to have a negative impact on mortality, perioperative adverse events, hospital length of stay as well as postoperative quality of life and functional status. Despite it being an important patient-centered outcome, postoperative quality of life tends to be overlooked when selecting patients for surgery.
Cardiac surgery presents a massive stressor to the frail patient, but on the other hand might have the ability to reduce disease burden and improve functional status, thus reducing frailty.
This prospective observational cohort study aims to assess frailty, as well as functional status and quality of life in cardiosurgical patients pre- and postoperatively, and evaluate its impact on postoperative clinical and functional outcomes.
The primary endpoint of this study is the change in postoperative level of frailty.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥ 60 years
- •elective cardiac surgery
排除标准
- •age < 60 years
- •emergency procedures
- •pulmonary thromboendarterectomy
- •declined informed consent
- •pregnant women
结局指标
主要结局
Change in Postoperative Level of Frailty
时间窗: 12 months
The "Clinical Frailty Scale" (CFS) will be used to assess frailty. A CFS of 1 indicates absence of frailty, whereas a CFS of 9 indicates severe frailty. A postoperative change in the CFS indicates a postoperative change in frailty.
次要结局
- Quality of Life assessed by the "SF-12 Patient Questionnaire"(12 months)
- Overall Mortality(12 months)
- 30-day Mortality(30 days)
- Functional Status assessed by the "Functional Independence Measure"(12 months)
研究者
Dr. Valerie-Anna Rudas
Resident Dept. of Anesthesia, Critical Care and Pain Medicine
Medical University of Vienna