Prostacyclin Treatment in Severe Traumatic Brain Injury: a Microdialysis and Outcome Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Lactate/pyruvate ratio 24 hours after start of epoprostenol versus placebo
研究概览
简要总结
This study is a prospective consecutive double-blinded randomized study on the effect of PGI2, prostacyclin (epoprostenol, Flolan®) versus placebo (saline)in patients with severe traumatic brain injury. All patients with severe traumatic brain injury were eligible for inclusion. Inclusion criteria: verified traumatic brain injury, Glasgow Coma Score (GCS) at intubation and sedation of ≤ 8, age 15-70 years, a first-recorded cerebral perfusion pressure (CPP) of > 10 mm Hg, and arrival within 24 hours after trauma.
Tne primary aim was to evaluate whether treatment with epoprostenol would reduce a lactate/pyruvate ratio,as measured by cerebral microdialysis after 24 hours of treatment.
A secondary aim was to evaluate the effect of epoprostenol on systemic inflammatory markers, measured by different cytokines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •traumatic brain injury, Glasgow coma scale ≤ 8
排除标准
- •pregnant or lactating women
研究组 & 干预措施
epoprostenol, Flolan®
Measurement on the effect of epoprostenol on lactate/pyruvate ratio measured by cerebral microdialysis
干预措施: epoprostenol versus normal saline (Drug)
normal saline
Effect of saline on the lactate/pyruvate ratio measured by cerebral microdialysis
干预措施: epoprostenol versus normal saline (Drug)
normal saline
Effect of saline on the lactate/pyruvate ratio measured by cerebral microdialysis
干预措施: normal saline (Drug)
结局指标
主要结局
Lactate/pyruvate ratio 24 hours after start of epoprostenol versus placebo
时间窗: 24 hours
次要结局
- Levels of systemic inflammatory markers(4 days)