Young Paul J, Bailey Michael J, Beasley Richard W, Freebairn Ross C, Hammond Naomi E, Haren Frank M P van, Harward Meg L, Henderson Seton J, Mackle Diane M, McArthur Colin J, McGuinness Shay P, Myburgh John A, Saxena Manoj K, Turner Anne, Webb Steve A R, Bellomo Rinaldo
Intensive Care Unit, Wellington Regional Hospital, Wellington, New Zealand.
Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Crit Care Resusc. 2017 Mar;19(1):81-87.
Body temperature can be reduced in febrile patients in the intensive care unit using medicines and physical cooling devices, but it is not known whether systematically preventing and treating fever reduces body temperature compared with standard care.
To describe the study protocol and statistical analysis plan for the Randomised Evaluation of Active Control of Temperature versus Ordinary Temperature Management (REACTOR) trial.
DESIGN, SETTING AND PARTICIPANTS: Protocol for a phase II, multicentre trial to be conducted in Australian and New Zealand ICUs admitting adult patients. We will recruit 184 adults without acute brain injury who are expected to be ventilated in the ICU beyond the day after randomisation. We will use open, random, parallel assignment to systematic prevention and treatment of fever, or to standard temperature management.
The primary end point will be mean body temperature, calculated from body temperatures measured 6-hourly for 7 days (168 hours) or until ICU discharge, whichever is sooner. Secondary end points are ICU-free days, in-hospital and cause-specific mortality (censored at Day 90) and survival time to Day 90 (censored at hospital discharge).
The trial will determine whether active temperature control reduces body temperature compared with standard care. It is primarily being conducted to establish whether a phase III trial with a patient-centred end point of Day 90 mortality is justified and feasible.
在重症监护病房中，可使用药物和物理降温设备降低发热患者的体温，但与标准护理相比，系统地预防和治疗发热是否能降低体温尚不清楚。
描述体温主动控制与常温管理随机评估（REACTOR）试验的研究方案和统计分析计划。
设计、地点和参与者：这是一项在澳大利亚和新西兰重症监护病房开展的针对成年患者的II期多中心试验方案。我们将招募184名无急性脑损伤且预计在随机分组后次日仍需在重症监护病房接受机械通气的成年患者。我们将采用开放、随机、平行分组的方式，分为系统预防和治疗发热组或标准体温管理组。
主要终点将是平均体温，通过每6小时测量一次体温，持续7天（168小时）或直至重症监护病房出院（以先到者为准）来计算。次要终点包括无重症监护病房天数、院内和特定病因死亡率（在第90天进行截尾）以及至第90天的生存时间（在出院时进行截尾）。
该试验将确定与标准护理相比，主动体温控制是否能降低体温。其主要目的是确定以第90天死亡率为以患者为中心的终点的III期试验是否合理且可行。
