Perioperative Copeptin: Predictive Value and Risk Stratification in Patients Undergoing Major Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 517
- 试验地点
- 2
- 主要终点
- composite events composed of all-cause mortality and/or major adverse cardiac and cerebrovascular events (MACCE)
研究概览
简要总结
Observational cohort study examining the perioperative course of copeptin in patients undergoing elevated-risk surgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults >18 years
- •Type of surgery for patients 1 to 30: abdominal aortic aneurysm repair, suprainguinal and infrainguinal vascular surgery, carotid surgery
- •Type of surgery for patients 31 to 500: surgeries with elevated risks in general (as specified by 2014 ESC/ESA Guidelines on non-cardiac surgery:
- •cardiovascular assessment and management [Kristensen])
排除标准
- •acute coronary Syndrome (ACS) at presentation (clinical assessment or documentation)
- •Congestive heart failure at presentation (clinical assessment or documentation)
- •Documented severe aortic stenosis (valve area <1cm2)
- •Kidney dysfunction (clearance <50ml/min)
- •Reduced left ventricular ejection fraction (LVEF) (<40%); if no LVEF is available, it will be assumed to be >40%
- •Cancelled surgery
- •Unwilling or unable to provide consent
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
结局指标
主要结局
composite events composed of all-cause mortality and/or major adverse cardiac and cerebrovascular events (MACCE)
时间窗: 12 months
MACCE defined as:non-fatal cardiac arrest, acute coronary syndrome (including MINS), congestive heart failure requiring hospitalization or transfer to a higher unit of care, and stroke
perioperative copeptin concentrations
时间窗: perioperative from induction of anesthesia to the third postoperative day
copeptin concentrations for the perioperative time course as measured by the ThermoFisher assay at induction, at 0h, 2h, 4h, 6h, 8h, as well as on the postoperative day 1 and 3.
myocardial injury in non-cardiac surgery (MINS)
时间窗: 3 postoperative days
次要结局
- all-cause mortality(12 months)
- composite events composed of all-cause mortality and/or major adverse cardiac and cerebrovascular events (MACCE)(30 days)