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临床试验/NCT04111055
NCT04111055已完成不适用

Feasibility of Computer-assisted Vasopressor Infusion Using Continuous Noninvasive Blood Pressure Monitoring in High-risk Patients Undergoing Renal Transplant Surgery

Erasme University Hospital2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2018年6月15日最近更新:
适应症

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

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

发起方
Erasme University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandre Joosten, MD PhD

Principal Investigator

Erasme University Hospital

研究点 (2)

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