Comparison Between the Neuroprotective Effect of Vitamin D Versus Dexmedetomidine in Patients with Traumatic Brain Injury Using Interleukin 6 As Inflammatory Marker
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary endpoint aims to measure the inflammatory markers level:
研究概览
简要总结
in this study the investigators compare between the neuroprotective effect of vitamin d versus dexmedetomidine in patients with traumatic brain injury using interleukin 6 as inflammatory biomarker
详细描述
patients with moderate head trauma (GCS 8-12) within first 24 hours were randomly divided into 2 groups, first group received 100,000 IU of vitamin D was given IM & the other group received dexmedetomidine 0.4 mic/kg as loading dose then 0.25 mic/kg/hr as maintainence dose for 5 days detecting APATCHE at admission and following up of vital signs (HR & NIBP) & investigations (CBC & RFT& ABG & ESR& CRP & IL-6) & GCS and GOS for 5 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both Gender.
- •Age (18-50)
- •GCS (8-12)
- •Pt with traumatic brain insult who not indicated surgical intervention
排除标准
- •Prior severe disability.
- •Isolated brain system lesions.
- •History of underlying neurologic, metabolic or psychiatric disorders.
- •Alcohol or drug abuse.
- •Pregnancy.
- •Patients with intracranial hemorrhage who indicated surgical evacuation.
- •Multisystem life-threatening trauma.
- •GCS > 12 & <
- •Vitamin d deficiency.
研究组 & 干预措施
group A
dexmedetomidine 0.4 mic/kg loading dose then 0.25 mic/kg/hr for 5 days
干预措施: Dexmedetomidine (Drug)
group B
vitamin D 100.000 IU given IM once
干预措施: Vitamin D3 (Drug)
结局指标
主要结局
The primary endpoint aims to measure the inflammatory markers level:
时间窗: 5 days
1- IL-6 in the unit of (pg/mL).
Primary outcome measure
时间窗: 5 days
3- CRP in the unit of (mg/L).
次要结局
- The secondary endpoints aim to compare ICU stay, morbidity and mortality in both groups:(3 months)
- Secondary outcome measure(3 month)
研究者
asmaa elhelw
Investigator
Minia University