NCT00751634已完成4 期
Temperature Control in Central Fever in the Neuro-ICU
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care
研究概览
简要总结
There are few treatments for central fever (fever that is due to the central nervous system, as opposed to an infectious source). We hypothesize that an externally applied cooling blanket will reduce temperature in neurologically ill patients with central fever.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Two or more days with core temperature ≥ 100.4F
- •Approval of the patient's primary attending physician
- •Need for core temperature measurement independent of the study.
- •Admission to the Neuro-ICU [intensive care unit] for an underlying condition
排除标准
- •Evidence for an infectious cause of fever, such as pneumonia, bacteremia, CNS [central nervous system] infection or urinary tract infection.
- •Expected death from any cause
- •Known sensitivity to the device
- •History of pre-admission hypothalamic dysfunction or known temperature dysregulation
- •Use of 2 or more vasopressor medications, since this may make a local skin reaction to the device more likely
- •Hemodynamic instability
结局指标
主要结局
Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care
时间窗: baseline, one, two and six hours after application.
Core temperature (in degrees Fahrenheit, F) throughout the study period. The cooling blanket was in place throughout the study period unless severe shivering led to termination per protocol.
次要结局
- Time From Start of Cooling Device to Core Temperature < 100.4F(Six hours)
- Number of Participants With Severe Shivering(six hours)
- Number of Participants With Hypotension(six hours)
- Number of Participants With Arrhythmia(Six hours)
研究者
Andrew Naidech
Associate Professor
Northwestern University
研究点 (2)
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