Advanced Cardiovascular Management in Major Non-cardiac Surgery. A Single Center, Randomized, Parallel, Open Label Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 534
- 试验地点
- 1
- 主要终点
- MINS and AKI incidence
研究概览
简要总结
This is a single center, randomised and controlled clinical triaI whose aim is to predict and treat in advance, intraoperative hypotension episodes.
In particular, the aim of the study is to compare the clinical impact of two different hemodynamic strategies based on the use of different monitoring platforms: the Edwards EV1000 equipped with FloTrac sensor and HemoSphere platform equipped with Acumen Hypotension Prediction Index software and Acumen IQ pressure sensor.
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
- None
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
- •Informed Consent as documented by signature (Appendix Informed Consent Form)
- •Age ≥ 18 years old
- •Surgical indication for major NCS needing general anesthesia
- •Anaesthesiologic indication for perioperative arterial cannulation and advanced hemodynamic monitoring
排除标准
- •Informed Refusal as documented by signature (Appendix Informed Consent Form)
- •Age ≤ 18 years old
- •Severe aortic valvulopathy
- •Atrial fibrillation
研究组 & 干预措施
High-risk adult patients undergoing major non cardiac surgery
Standard GDT strategy
干预措施: GDT strategy (Device)
high-risk adult patients undergoing major non cardiac surgery
HPI-driven intraoperative hemodynamic management strategy
干预措施: HPI-driven intraoperative hemodynamic management strategy (Device)
结局指标
主要结局
MINS and AKI incidence
时间窗: within 3 and 7 days after surgery
Clinical impact of any reduction in IOH occurrence or severity
次要结局
- Mortality(30 days)
- Cardiac damage(from day 1 to 3)
- kidney damage(day 1, day 2 and day 7)
- hypotensive events(2 years)
研究者
Alessandro Locatelli
MD
Fondazione IRCCS Policlinico San Matteo di Pavia