Controlled Mean Arterial Pressure of Brain Injury Patients Using an Novel Automated System for Vasopressor Administration : a Randomized Controlled Trial in Critically Ill Patients in the Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Mean arterial pressure (MAP)
研究概览
简要总结
The goal of this randomized controlled trial will be to show that the use of a novel automated system to guide vasopressor administration in brain injury patients will results in more time spent with a mean arterial pressure (MAP) within the predefined MAP (+/- 5 mmHg of the target MAP) compared to patients managed without any automated system (manually management)
详细描述
In brain injury patients, the maintenance of MAP within a very narrow range is desired to avoid complications related to hypoperfusion (undertreatment) or hypertension (over treatment). However, the MAP needed to reach can vary over time based on intracranial pressure. Additionally, it is well know that the nurses in the Intensive care unit managed multiple patients simultaneously and cannot dedicate 100% of his-her time to adjust drugs infusions. Using a novel automated system can overcome this issue and may lead to more time in MAP target (+/- 5mmHg) than the traditional management.
After initial rescuscitation of the patients, patients in both groups will have the same baseline maintenance fluid administration of 1-2 ml/kg/h of crystalloid solution and additionnal fluid boluses administered following the EV1000 monitoring device. The only difference will be the management of vasopressor titration (manual by nurses vs automated via a closed-loop system)
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
- Single (Participant)
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
- •severe brain injury patients (Glasgow score <9), intubated, ventilated and sedated.
排除标准
- •Glasgow score > 8
- •Bilateral mydriasis at the initial management (Ambulance and first hour of arrival)
结局指标
主要结局
Mean arterial pressure (MAP)
时间窗: 48 hours post-admission in the intensive care unit
percentage of treatment time when MAP will be in the predefined range (+/- 5 mmHg of the target MAP)
次要结局
- Percentage of case time spent in Hypotension(48 hours post-admission in the intensive care unit)
- stroke volume(48 hours post-admission in the intensive care unit)
- cardiac index(48 hours post-admission in the intensive care unit)
- Transcranial doppler(48 hours post-admission in the intensive care unit)
- Fluid received(48 hours post-admission in the intensive care unit)
- Percentage of case time spent Hypertension(48 hours post-admission in the intensive care unit)
- Cerebral perfusion pressure(48 hours post-admission in the intensive care unit)
- Intracranial pressure Hypertension(48 hours post-admission in the intensive care unit)
- Intracranial pressure(48 hours post-admission in the intensive care unit)
- mean arterial pressure (MAP)(48 hours post-admission in the intensive care unit)
- Amount of vasopressor(48 hours post-admission in the intensive care unit)
- Length of stay in the intensive care unit(30 days post-admission in the intensive care unit)