Closed-loop Control of Vasopressor Infusion in Critically Ill Patients: A Case Series
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Percentage of case Time in hypotension (MAP <72 mmHg)
研究概览
简要总结
The purpose of this case series is to evaluate the performance of a novel closed-loop (automated) vasopressor administration system that delivers norepinephrine using feedback from standard hemodynamic monitor (EV1000 Monitor) from Edwards Lifesciences (IRVINE, USA) in critically ill patients
详细描述
In this protocol, the investigators will report the percentage of case time in hypotension (defined as Mean arterial pressure (MAP) < 72mmHg) during a two hours study protocol in critically ill patients.
The target MAP will be set at 80 mmHg, and the definition of hypotension is a MAP < 90% of MAP target ( 80 mmHg - 10% = 72 mmHg)
The investigators want to demonstrate that the closed-loop system can prevent hypotension at this specific set point.
The investigators will test the system in a short series of 10-12 critically ill patients in the ICU setting during a two hours study protocol.
Participants will receive standard patient care
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
- •All patients in the intensive care unit (awake or under sedation)
- •Requiring norepinephrine to maintain a MAP of 80 mmHg
- •Equiped with an arterial line
排除标准
- •Subjects under 18 years of age
- •Subject with Atrial Fibrillation
- •Subjects who are pregnant
结局指标
主要结局
Percentage of case Time in hypotension (MAP <72 mmHg)
时间窗: During thetwo hours study protocol
The primary outcome will be the percentage of case time in predefined MAP target
次要结局
- percentage of case time with MAP >88 mmHg with norepinephrine still running(During the two hours study protocol)
- Amount of vasopressors received(During the two hours study protocol)
研究者
Alexandre Joosten, MD PhD
Principal Investigator
Erasme University Hospital