Impact of Fever Prevention in Brain Injured Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 686
- 试验地点
- 75
- 主要终点
- Fever Burden
研究概览
简要总结
This study will assess the impact of fever prevention on fever burden and short- and long-term neurologic outcomes in brain injured patients. Half of the subjects will undergo fever prevention using a targeted temperature management system and half of the subjects will be treated for fever should it develop.
详细描述
Multiple studies demonstrate that fever / elevated temperature is associated with poor outcomes in brain injured patients; however, there are no conclusive studies that demonstrate that fever prevention/controlled normothermia is associated with better outcomes. This study will be conducted to assess the impact of advanced temperature control to prevent fever in brain injured patients. The fever prevention group will use the Arctic Sun Temperature Management System and will be compared to standard care patients in whom fever may spontaneously develop. If fever develops in a patient in the standard care group, they will be treated with standard fever care measures according to a step-wise algorithm, consisting primarily of intermittent antipyretics (e.g., acetaminophen) and cooling blankets and, when necessary, advanced targeted temperature management devices.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted with a primary neurological diagnosis of ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage
- •Prior to onset of acute symptoms, was considered functionally independent (mRS 0-2)
- •Meets disease-specific criteria
排除标准
- •Fever (≥38°C) prior to study enrollment
- •Pre-existing neurological, psychiatric, or other condition that would confound neurological assessment or would make it difficult to accurately assess neurologic and/or functional outcome
- •Has a pre-morbid condition with poor likelihood of survival to 6 months
- •Has a pre-morbid mRS ≥3
- •Diagnosed with brain death
- •Is undergoing therapeutic hypothermia therapy
- •Has sustained neurological injury felt to be catastrophic with little chance of recovery
- •Has a skin condition in which the use of the ArcticGel Pads is contraindicated (i.e., skin that has signs of ulceration, burns, hives, or rash)
- •Has poor skin integrity or poor tissue perfusion
- •Participation in a concurrent investigational / interventional study (medical device or drug)
结局指标
主要结局
Fever Burden
时间窗: Up to 14 days
Daily average fever burden (°C-hour)
次要结局
- Other Neurologic Outcomes: Glasgow Outcome Scale Extended Short-Term(3-months post injury)
- Other Neurologic Outcomes: Montreal Cognitive Assessment Short-Term(3-months post injury)
- Other Neurologic Outcomes: Barthel Index Short-Term(3-months post injury)
- Other Neurologic Outcomes: Montreal Cognitive Assessment Mid-Term(6-months post injury)
- Other Neurologic Outcomes: NIH Stroke Scale Short-Term(3-months post injury)
- Other Neurologic Outcomes: Glasgow Outcome Scale Extended Mid-Term(6-months post injury)
- Other Neurologic Outcomes: NIH Stroke Scale Mid-Term(6-months post injury)
- Primary Neurologic Outcome: Modified Rankin Scale Long-Term(12-months post injury)
- Major Adverse Events(From date of randomization until end of study, assessed up to 12 months)
- Number of Participants With Infection(From date of randomization until hospital discharge, assessed up to 30 days)
- Number of Subjects With Shivering(Up to 14 days)
- Primary Neurologic Outcome: Modified Rankin Scale Short-Term(3-months post injury)
- Primary Neurologic Outcome: Modified Rankin Scale Mid-Term(6-months post injury)
- Adverse Events(From date of randomization until hospital discharge, assessed up to 30 days)
- Other Neurologic Outcomes: Barthel Index Mid-Term(6-months post injury)