Multimodal Neuromonitoring in Patients With Severe Acute Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The predictive value of glutamate measured by intracerebral microdialysis for 6-month functional outcome
研究概览
简要总结
Acute brain injury due to aneurysmal subarachnoid haemorrhage (SAH) or traumatic brain injury (TBI) is a condition with a high mortality, and surviving patients often have permanent disabilities. Multimodal neuromonitoring of intracranial pressure, brain tissue oxygen tension (PbtO2), and brain energy metabolism (measured with microdialysis (MD)) may help individualise the treatment of this patient group to protect the brain and potentially improve outcomes. However, there is still a significant lack of knowledge regarding the advantages and disadvantages of this type of monitoring.
The present study consists of four substudies with the overall aim of examining which factors are most influential for regulating commonly measured intracerebral parameters such as oxygenation, glucose, and lactate. Additionally, the influence of these of parameters on functional outcome and mortality will be explored.
The individual studies are detailed below:
详细描述
Substudy 1:
This study investigates the relationship between glucose in blood and microdialysate (MD-glucose) in patients with severe traumatic brain injury (TBI) or aneurysmal subarachnoid haemorrhage (SAH).
Substudy 2:
The aim of this substudy is to examine the contribution of arterial oxygen tension (PaO2) to PbtO2 in patients with acute brain injury. We hypothesize that there is an association between the two parameters, that this relationship is altered in patients with concurrent intracranial hypoertension, and that a higher burden of cerebral hypoxia is associated with poor functional outcome and mortality.
Substudy 3:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients admitted to the Neurointensive care unit at Rigshospitalet, Copenhagen
- •Diagnosis of traumatic brain injury or subarachnoid haemorrhage
- •Multimodal neuromonitoring consisting intracranial pressure, brain tissue oxygen tension, and/or cerebral microdialysis
排除标准
- •Age below 18 years
- •Acute brain injury due to causes other than the above mentioned
结局指标
主要结局
The predictive value of glutamate measured by intracerebral microdialysis for 6-month functional outcome
时间窗: Throughout the duration of neuromonitoring in the neuro-ICU (1-30 days)
Modified Rankin Scale
Median goodness of fit (Pearsons R2) of the relationship between PaO2 (kPa) and PbtO2 (mmHg).
时间窗: Throughout the duration of neuromonitoring in the neuro-ICU (1-30 days)
Median goodness of fit (Pearsons R2)
Correlation between systemic lactate and microdialysis lactate when corrected for PbtO2 and cerebral perfusion pressure.
时间窗: Throughout the duration of neuromonitoring in the neuro-ICU (1-30 days)
Median goodness of fit (Pearsons R2)
The predictive value of glutamate measured by intracerebral microdialysis for episodes of neuroworsening
时间窗: Throughout the duration of neuromonitoring in the neuro-ICU (1-30 days)
Area under the curve
Correlation between systemic glucose and microdialysis glucose
时间窗: Throughout the duration of neuromonitoring in the neuro-ICU (1-30 days)
Median goodness of fit (Pearsons R2)
次要结局
- Mortality at six months(Six months after admission to the neuro-ICU)
- Functional outcome at six months(Six months after admission to the neuro-ICU)
- Length of hospital stay(From admission until discharge (1-300 days))
- Mixed effects linear regression of the relationship betwen PaO2 (kPa) and PbtO2 (mmHg).(Six months after admission to the neuro-ICU)
- Length of stay in the ICU(From admission until discharge from the ICU (1-300 days))
研究者
Anne-Sophie Worm Fenger
MD, PhD fellow
Rigshospitalet, Denmark