Effects of Dexmedetomidine on Inflammatory Cytokines in Patients With Aneurysmal Subarachnoid Hemorrhage
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Changes between serum and CSF cytokines over 48 hours
研究概览
简要总结
The purpose of this research is to compare patients with aneurysmal subarachnoid hemorrhage on dexmedetomidine compared to propofol to assess if one group has decreased inflammation. The investigators hypothesis is that the group assigned to receive dexmedetomidine will have a more profound decrease in markers of inflammation over time.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aneurysmal subarachnoid hemorrhage
- •World Federation of Neurological Surgeons (WFNS) grade 4-5 (see table below)
- •Surgical intervention with clip or coil
- •Placement of cerebrospinal fluid drain (lumbar or ventricular)
- •Mechanically ventilated at start of infusion
排除标准
- •Hemodynamic instability (SBP < 100, HR <60, or on continuous infusion of catecholamines) at screening
- •Heart failure class III or IV (New York Heart Association)
- •Renal failure (RIFLE classification - see table below)
- •Liver failure (serum protein < 3 g/dL and total bilirubin > 5 mg/dL)
- •Known or suspected brain death
- •Pregnancy
- •Unable to receive dexmedetomidine within 48 hours of injury and 4 hours of surgery
- •Allergy to dexmedetomidine
- •Prisoners
研究组 & 干预措施
Propofol
干预措施: propofol (Drug)
Dexmedetomidine
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Changes between serum and CSF cytokines over 48 hours
时间窗: 0, 24 and 48 hours
Measure the baseline level (at enrollment) of inflammatory markers tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), glial fibrially acidic protein (GFAP), and malondialdehyde (MDA) as measured in both serum and cerebrospinal fluid (CSF) in 10 patients with aneurysmal subarachnoid hemorrhage (aSAH).
次要结局
- Hospital length of stay(2 weeks)
- Glasgow Outcome Scores Extended (GOSE) at discharge(2 weeks)
- Sedative and analgesic medication requirements(2 weeks)
- Incidence of delayed cerebral ischemia (DCI)(2 weeks)
- Sedation scores (RASS and CAM-ICU)(2 weeks)
- ICU length of stay(2 weeks)
研究者
Shaun Keegan
Clinical Pharmacy Specialist, Critical Care
University of Cincinnati