Feasibility of Computer-assisted Vasopressor Infusion Using Continuous Noninvasive Blood Pressure Monitoring in High-risk Patients Undergoing Renal Transplant Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Percentage of case time in hypotension
研究概览
简要总结
Intraoperative hypotension and blood pressure variability are associated with postoperative complications in surgical patients.
The investigators have developed a closed-loop vasopressor (CLV) controller that titrates norepinephrine to correct hypotension.
After having tested the system in a small cohort series of patients undergoing major surgeries, the investigators aimed to test the feasibility of the CLV controller guided noninvasively and continuously with the ClearSight system (Edwards Lifesciences, USA) in three high risk patients undergoing renal transplant surgery
详细描述
Intraoperative hypotension is frequent in patients undergoing surgery and can negatively impact organ perfusion.
The investigators have developed a closed-loop vasopressor (CLV) controller to more efficiently correct hypotension.
The investigators tested it extensively in preclinical studies and recently demonstrated its feasibility and excellent performance metrics in a short series of high-risk patients undergoing major surgical procedures.
In these studies, the controller was linked to a minimally-invasive advanced hemodynamic monitoring device utilizing an arterial line which then controlled a vasopressor infusion. However, the vast majority of patients who undergo surgery do not require an arterial line but should still benefit from rapid corrections of hypotensive episodes that are less rapidly detected via an intermittent non-invasive blood pressure cuff. Fortunately, completely noninvasive technology now allows us to continuously monitor blood pressure and therefore extend the use of our closed-loop vasopressor system to patients in whom an arterial catheter would not typically be placed. Patients undergoing renal transplant surgeries are the ideal patient population.
The investigators aimed to test the feasibility of guiding our CLV controller with a continuous noninvasive blood pressure monitoring device (ClearSight system, Edwards Lifesciences, Irvine, CA, USA) in three patients (case series)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult high risk patients undergoing renal transplant surgery
- •Patients equipped with a clearsight advanced hemodynamic monitoring system
排除标准
- •Atrial fibrillation
- •No consent obtained from the patient.
- •Ejection fraction < 30%
结局指标
主要结局
Percentage of case time in hypotension
时间窗: during surgery
% of case time without hypotension. MAP of at least 5mmHg below the chosen CLV target
次要结局
- Incidence of acute kidney injury(30 days postsurgery)
- Amount of vasopressor used(during surgery)
- Percentage of active treatment time spent in a hypertensive state(during surgery)
研究者
Alexandre Joosten, MD PhD
Principal Investigator
Erasme University Hospital
