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临床试验/NCT05323149
NCT05323149招募中3 期

The Impact of Early Use of Dexamethasone Traumatic Brain Injury Upon the Inflammatory Response and Outcome

Assiut University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年5月18日最近更新:
适应症
干预措施
相关药物

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

  1. 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).
  2. 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

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

Placebo Comparator

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omar Makram Soliman

Lecturer of anesthesia and ICU

Assiut University

研究点 (2)

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