Cerebral Perfusion Pressure Using Precedex and Other Sedatives
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Variability of Intracranial Pressure (ICP)
研究概览
简要总结
The purpose of this study is to examine the effects of using dexmedetomidine (Precedex) in addition to the current standard-of-care for sedation.
详细描述
Primarily, this study seeks to explore whether there is a difference in mean arterial pressure (MAP) variability, incidence of intracranial hypertension, intracranial pressure (ICP) variability, cerebral perfusion pressure (CPP) and Cerebrovascular pressure reactivity index (PRx) in two groups of subjects.
Patients must be submitted to the ICU and be endotracheally intubated and receiving mechanical ventilation with continuous IV sedation for less than 24 hours after recruitment into the study.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Admitted to Duke University Neuro Critical Care Unit (NCCU)
- •Adult (18 years of age or older)
- •Expected Mechanical Ventilation for >48 hours with sedation
- •Intraventricular catheter in situ
排除标准
- •Hypersensitivity to study drugs
- •Prisoners
- •Moribund state or death expected within 24 hours
- •Surgery planned within 24 hours of subject enrollment
- •Receiving study drug, Precedex, prior to entering study
研究组 & 干预措施
Standard-of-Care plus Precedex
Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment.
干预措施: Standard-of-Care plus Dexmedetomidine (Drug)
Standard-of-Care
Subjects who are treated with the standard of care sedation regiment only.
干预措施: Standard-of-Care (Other)
结局指标
主要结局
Variability of Intracranial Pressure (ICP)
时间窗: Baseline to 24 hours
Variability of intracranial pressure was assessed and listed as the standard deviation of all measurements within 24 hours. Variability was assessed and listed as the standard deviation of all measurements within 24 hours
Change in Pressure Reactivity Index (PRx)
时间窗: Baseline to 24 hours
Using computational methods, the PRx was determined by calculating the correlation coefficient between 20 consecutive, time-averaged data points (60-second periods) of ICP and Arterial Blood Pressure (ABP). A positive PRx correlation suggests impaired cerebrovascular pressure reactivity, that is, passive transmission of changes in ABP to ICP. A negative PRx correlation indicates good pressure reactivity. Any change in ABP produces inverse changes in ICP.
次要结局
- Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury(Baseline to 24 hours)
- Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury(24 hours)
- Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury(Baseline to 24 hours)