Impact of Cardiac Blood Flow on Cerebral Blood Flow in Patients With Severe Traumatic Brain Injury
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean blood flow velocity
研究概览
简要总结
Severe traumatic brain injury with increased intracranial pressure can lead to decreased cerebral blood flow. Low cerebral blood flow is responsible for secondary lesions, leading to bad prognosis. It is not yet established whether increasing cardiac output in these patients can lead to an increase in cerebral blood flow, although there are some arguments in favor of this hypothesis. The aim of this study is to demonstrate that increasing cardiac output will improve cerebral blood flow in patients with severe traumatic injury and high cerebral pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic brain injury (TBI) with pattern of oligemia (diastolic velocity < 30cm/second and/or mean velocity < 45cm/second measured with transcranial doppler or oxygen tissue pressure < 15mmHg)
- •Closed traumatic brain injury
- •Isolated TBI or polytraumatism
- •Age between 18 and 65 years old
- •Affiliated to a social security system
排除标准
- •Instable episodes of high cerebral pressure
- •Craniectomy
- •High cerebral pressure without TBI
- •No autoregulation
- •Current hemorrhagic shock
- •Chronic cardiac failure
- •Chronic renal failure
- •Hyperemia measured with transcranial doppler
- •Short life expectancy
- •Refused consent from the family
- •Protected patients by the law
- •Hypersensibility to one of the treatment or sulfites
研究组 & 干预措施
Noradrenaline alone
Treatment for 30 minutes with noradrenaline alone
干预措施: Norepinephrine (Drug)
Noradrenaline + dobutamine
Treatment with noradrenaline and dobutamine for 30 minutes
干预措施: Dobutamine and norepinephrine (Drug)
结局指标
主要结局
Mean blood flow velocity
时间窗: After one hour of treatment
Mean blood flow velocity averaged on the two middle cerebral arteries (right and left) measured one after after the initiation of treatment. Each velocity is calculated as an average on the 10 last minutes form continuous transcranial doppler monitoring
次要结局
- Resistivity index on renal doppler(After one hour of treatment)
- Pulsatility index on renal doppler(After one hour of treatment)
- Evolution of brain oxygenation under treatment(During one hour of treatment)
- Dobutamine doses(After one hour of treatment)
- Cardiac output modifications(During one hour of treatment)