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临床试验/NCT00890604
NCT00890604已完成不适用

Outcomes Associated With the Application of the Normothermia Protocol in Patients With Severe Neurological Insult and Fever

University of Washington1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Glasgow Coma Score

研究概览

简要总结

When fever is present in patients with stroke, traumatic brain injury (TBI), or brain hemorrhage, it has been associated with worse outcomes including larger areas of tissue death, increased length of stay, worse degree of coma, lower ability to function, and higher mortality. Both adult and pediatric TBI national guidelines state that maintenance of normal body temperature should be a standard of care. However, no further standards or options are presented to specifically guide practice. The current ischemic stroke guidelines state that fever should be treated with fever-reducing agents and offer "cooling devices" as an option but do not provide specifics to guide practice. Over 50% of patients in the Neurosurgical Intensive Care Unit (ICU) at Harborview Medical Center develop fever during the course of their stay. With elevated temperatures the body consumes more oxygen than if the temperature was normal, causing less oxygen to be available to the brain. This may lead to injury of the brain cells and a diminished capacity for healing. Thus, temperature management in neurologically vulnerable patients is both a prevalent and problematic challenge. Based on this information the goal of the present proposal is to evaluate if 1) A standardized, step-wise approach to temperature management using a Normothermia Protocol is successful in achieving and maintaining normal temperature in Neurosurgical ICU patients; and 2) If maintenance of normal temperature will be associated with fewer episodes of diminished responsiveness in their neurological exams as evidenced by a measure of depth of coma, as measured by the Glasgow Coma Score (GCS) compared to a control group treated according to usual care.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Temperature > 38.3 Celsius
  • Meet brain injury criteria:
  • Traumatic brain injury with Glasgow Coma Scale score of 8 or less
  • Subarachnoid hemorrhage without vasospasm- Hunt and Hess grade III and below
  • Subarachnoid hemorrhage with vasospasm
  • First febrile episode
  • English speaking

排除标准

  • Skin breakdown
  • Bleeding disorders
  • Increased risk for clotting
  • Ongoing seizure activity
  • Allergy to medications used in the study

研究组 & 干预措施

Standard interventions for temperature control used in protocolized, stepwise fashion

Other

Normothermia Protocol- use of standard interventions in protocolized fashion (physical cooling, antipyretics)

干预措施: Stepwise normothermia protocol (Other)

Standard interventions for temperature control used in protocolized, stepwise fashion

Other

Normothermia Protocol- use of standard interventions in protocolized fashion (physical cooling, antipyretics)

干预措施: Ibuprofen (Drug)

Standard interventions for temperature control used in protocolized, stepwise fashion

Other

Normothermia Protocol- use of standard interventions in protocolized fashion (physical cooling, antipyretics)

干预措施: Acetominophen (Drug)

结局指标

主要结局

Glasgow Coma Score

时间窗: 24 hour

次要结局

  • temperature(hourly)
  • length of stay (intensive care, hospital)(discharge)

研究者

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

Hilaire Thompson

Professor: School of Nursing

University of Washington

研究点 (1)

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