The Impact of Early Use of Dexamethasone Traumatic Brain Injury Upon the Inflammatory Response and Outcome
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Percentage of patients with decreased the inflammatory response
研究概览
简要总结
In this study, our aim is to investigate the role of Dexamethasone for modulating the inflammation in patients with traumatic brain injury (TBI).
详细描述
This is double-blind trial, where group D will be received Dexamethasone, where group C will be received saline placebo.
In emergency room (ER), trauma patients will be assessed and managed according to our local hospital protocol. After the initial resuscitation of patients. The selection was done according to the inclusion criteria. Baseline investigations
- C-reactive protein (CRP), interleukin -6(IL-6), C-reactive protein/Albumin ratio (CAR), complete blood count (CBC) for neutrophil lymphocyte ratio (NLR), platelet lymphocyte ratio (PLR).
- Prothrombin concentration (PC), prothrombin time (PT), activated partial thromboplastin time (aPTT), and INR.
Group D, will be received Dexamethasone (loading dose of 10 mg in 5 ml saline, followed by a 8 mg in 5 ml saline of maintenance dose every 6 hours for 48 h). Group C, will be received saline (loading dose of 5 ml saline 0.9%, followed by a 5 ml saline 0.9% of maintenance saline dose every 6 hours for 48 h) to monitor the post-interventional inflammatory response (CBC for NLR, PLR), CRP, IL-6, C-reactive protein/Albumin ratio (CAR), hemostasis (PC, PT, activated PTT, and international normalized ratio (INR)) and short-term outcome. Conscious level will be assessed by Glasgow come scale (GCS), delirium by Richmond Agitation-Sedation Scale (RASS score) and hemodynamics will be continuously monitored. Patients will be monitored and managed in intermediate or intensive care unit. Adverse effects and complications will be recorded and managed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Isolated traumatic brain injury patients (mild or moderate cases)
- •non penetrating TBI in 8 hours onset
- •Age ≥ 18 years
排除标准
- •Patient in cardiac arrest
- •Patients with coagulopathies
- •All diabetic patients
- •Renal failure patients
- •pregnancy
- •Patient refusal to participate
研究组 & 干预措施
Group C
Group C, will be received saline (loading dose of 5 ml of saline 0.9%, followed by a 5 ml saline 0.9% of maintenance saline dose every 6 hours for 48 h).
干预措施: Saline (Other)
Group D
Group D, will be received Dexamethasone (loading dose of 10 mg Dexamethasone in 5 ml saline, followed by a 8 mg diluted in 5 ml saline of maintenance dose every 6hours for 48 h).
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Percentage of patients with decreased the inflammatory response
时间窗: 48 hours post-interventional (either placebo or Dexamethasone)
Percentage of patients with decreased the inflammatory response, as assessed by NLR measurements
Percentage of patients with decreased the inflammatory response
时间窗: 48 hours post-interventional (either placebo or TXA)
Percentage of patients with decreased the inflammatory response, as assessed by NLR measurements
次要结局
未报告次要终点
研究者
Omar Makram Soliman
Lecturer of anesthesia and ICU
Assiut University
