发热观察研究
危重患儿意外入院儿科重症监护室感染性发热流行病学观察研究
To inform the feasibility of conducting a study to test different temperature thresholds at which clinicians deliver interventions to reduce fever (i.e. antipyretic interventions) in critically ill children with fever due to infection.
研究概览
地位
条件
详细说明
Fever (high temperature) is a normal bodily response to an infection, which has shown to have a beneficial effect in humans with chickenpox, malaria and rhinovirus infections. In children it has been recommended by the National Institute for Health and Care Excellence not to cool down the child using drugs or physical methods such as a cooling mat, with the sole aim to reducing the child's temperature. However, this recommendation is not aimed at the management of critically ill children, to which there is uncertainty around use of cooling interventions when considering the advantages of a fever in defending the body against viruses and bacteria during critical illness, and weighing that up with the possible negative physiological consequences of a high fever e.g. increased metabolic rate.
Observational studies show that the treatment of fever in critically ill children is inconsistent. There is a lack of robust data to guide antipyretic intervention, with clinicians usually starting fever management at around 37.5°C. Evidence is emerging that fever may be beneficial in critically ill adults. Due to the physiological differences between adults and children there is an important need to evaluate whether a different approach to fever management in critically ill children may also be beneficial.
Prior to conducting a large, expensive, randomised clinical trial (RCT) to evaluate whether a higher temperature threshold in starting treatments to cool down the child would be beneficial, we are conducting three studies to know if it is possible for us to test key outcome measures as a result of testing different temperatures thresholds for antipyretic management.
The Fever Observational Study is one of these studies, with the aim of identifying: the potential population that would be eligible for the proposed definitive trial, current temperature threshold(s) for fever management, and to describe the characteristics of outcome measures with the intention of deciding on a main measure to see which treatment method was more successful.
研究类型
注册 (实际的)
联系人和位置
学习地点
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London、英国、WC1V 6AZ
- Intensive Care National Audit and Research Centre
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
All unplanned admissions to a PICU
描述
Inclusion Criteria:
unplanned PICU admission referral requiring PICU admission to a participating unit
学习计划
研究是如何设计的?
设计细节
- 观测模型:COHORT
- 时间观点:PROSPECTIVE
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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确定符合提议的最终试验资格标准的患者数量。
大体时间:基线
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基线
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英国至少 20 个儿科重症监护病房 (PICU) 目前采用的温度阈值
大体时间:前 5 个日历日
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前 5 个日历日
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通气时长 - 平均值(标准差)
大体时间:通过学习完成,平均2天
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通过学习完成,平均2天
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PICU 停留时间 - 平均值(标准差)
大体时间:通过学习完成,平均2天
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通过学习完成,平均2天
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PICU 死亡率 - 人数(百分比)
大体时间:通过学习完成,平均2天
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通过学习完成,平均2天
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住院死亡率 - 人数(百分比)
大体时间:通过学习完成,平均2天
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通过学习完成,平均2天
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器官特定支持天数 - 平均值(标准差)
大体时间:通过学习完成,平均2天
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通过学习完成,平均2天
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合作者和调查者
合作者
调查人员
- 首席研究员:Mark Peters, MBChB, PhD、Institute of Child Health
出版物和有用的链接
一般刊物
- Deja E, Peters MJ, Khan I, Mouncey PR, Agbeko R, Fenn B, Watkins J, Ramnarayan P, Tibby SM, Thorburn K, Tume LN, Rowan KM, Woolfall K. Establishing and augmenting views on the acceptability of a paediatric critical care randomised controlled trial (the FEVER trial): a mixed methods study. BMJ Open. 2021 Mar 10;11(3):e041952. doi: 10.1136/bmjopen-2020-041952.
- Peters MJ, Khan I, Woolfall K, Deja E, Mouncey PR, Wulff J, Mason A, Agbeko R, Draper ES, Fenn B, Gould DW, Koelewyn A, Klein N, Mackerness C, Martin S, O'Neill L, Ramnarayan P, Tibby S, Tume L, Watkins J, Thorburn K, Wellman P, Harrison DA, Rowan KM. Different temperature thresholds for antipyretic intervention in critically ill children with fever due to infection: the FEVER feasibility RCT. Health Technol Assess. 2019 Feb;23(5):1-148. doi: 10.3310/hta23050.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IRAS 209929
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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