Beta Blocker Effects on Patients With Traumatic Brain Injury
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- survival
研究概览
简要总结
The study will be conducted on polytrauma patient who are admitted from emergency room or postoperative with head trauma to evaluate effects of beta blocker on patients with TBI.
详细描述
The study will be conducted on polytrauma patient who are admitted from emergency room or postoperative with head trauma . Patients will be randomly assigned into two groups by sealed envelope technique into two equal groups.
Parameters assessment:
- Length of ICU stay
- Length of total hospital stay
- CT scan to exclude another intracranial hemorrhage or increase in hemorrhage
- Functional status will be assessed using the GCS
- Hemodynamic data ( bl.p / hr )
- Crystalloid volume that patient need in 24h
- Mortality rate
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GCS preoperative >10
- •Abbreviated Injury Scale (AIS) >3
- •Length stay in ICU >48 h
排除标准
- •Hypersensitivity to propranolol
- •Asthmatic patient
- •History of smoking
- •Any cardiac problems eg: ( heart failure or HB )
- •pheochromocytoma
- •Pregnant patient
- •Length stay <48h
- •Death within 48 h of admission
- •Patient who previously received any beta blocker at home.
- •Symptomatic Bradycardia <60 b/m (sick sinus syndrome)
- •Hemodynamic unstable patients
研究组 & 干预措施
beta blocker
Will be given Propranolol 1mg in 10 ml distilled water intravenous every 6 hours for 48 hours
干预措施: Propranolol (Drug)
placebo
Will be given normal saline 10 ml every 6 hours for 48 hours
干预措施: Saline (Drug)
结局指标
主要结局
survival
时间窗: 7 days
number of surviving in patients receiving propranolol and patients who did not receive any beta blocker
次要结局
- heart rate(7 days)
- icu stay(7 days)
研究者
mostafa saieed fahim mansour
lecturer
Menoufia University