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Protocol and statistical analysis plan for the Randomised Evaluation of Active Control of Temperature versus Ordinary Temperature Management (REACTOR) trial

Young, Paul; Bailey, Michael; Beasley, Richard W; Freebairn, Ross; Hammond, Naomi; Van Haren, Frank; Harward, Meg L; Henderson, Seton J; Mackle, Diane; McArthur, Colin; McGuinness, Shay P.; Myburgh, John; Saxena, Manoj K; Turner, Anne; Webb, Steve AR; Bellomo, Rinaldo

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BACKGROUND: 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. OBJECTIVE: 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...[Show more]

dc.contributor.authorYoung, Paul
dc.contributor.authorBailey, Michael
dc.contributor.authorBeasley, Richard W
dc.contributor.authorFreebairn, Ross
dc.contributor.authorHammond, Naomi
dc.contributor.authorVan Haren, Frank
dc.contributor.authorHarward, Meg L
dc.contributor.authorHenderson, Seton J
dc.contributor.authorMackle, Diane
dc.contributor.authorMcArthur, Colin
dc.contributor.authorMcGuinness, Shay P.
dc.contributor.authorMyburgh, John
dc.contributor.authorSaxena, Manoj K
dc.contributor.authorTurner, Anne
dc.contributor.authorWebb, Steve AR
dc.contributor.authorBellomo, Rinaldo
dc.date.accessioned2021-09-06T04:47:10Z
dc.identifier.issn1441-2772
dc.identifier.urihttp://hdl.handle.net/1885/247379
dc.description.abstractBACKGROUND: 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. OBJECTIVE: 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. MAIN OUTCOME MEASURES: 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). RESULTS AND CONCLUSIONS: 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.
dc.description.sponsorshipOur study is endorsed by the Australian and New Zealand Intensive Care Society Clinical Trials Group and funded by the Health Research Council of New Zealand (16/488). The study is coordinated in New Zealand by the Medical Research Institute of New Zealand (MRINZ) and in Australia by the the George Institute for Global Health. The MRINZ is supported by research organisation funding from the Health Research Council of New Zealand.
dc.format.mimetypeapplication/pdf
dc.language.isoen_AU
dc.publisherAustralasian Academy of Critical Care Medicine
dc.rightsCollege of Intensive Care Medicine of Australia and New Zealand
dc.sourceCritical Care and Resuscitation
dc.titleProtocol and statistical analysis plan for the Randomised Evaluation of Active Control of Temperature versus Ordinary Temperature Management (REACTOR) trial
dc.typeJournal article
local.description.notesImported from ARIES
local.identifier.citationvolume19
dc.date.issued2017
local.identifier.absfor110310 - Intensive Care
local.identifier.ariespublicationu6048437xPUB432
local.publisher.urlhttp://www.cicm.org.au/
local.type.statusPublished Version
local.contributor.affiliationYoung, Paul, Wellington Regional Hospital
local.contributor.affiliationBailey, Michael, Monash University
local.contributor.affiliationBeasley, Richard W, Medical Research Institute of New Zealand
local.contributor.affiliationFreebairn, Ross, Medical Research Institute of New Zealand
local.contributor.affiliationHammond, Naomi, George Institute for Global Health
local.contributor.affiliationVan Haren, Frank, College of Health and Medicine, ANU
local.contributor.affiliationHarward, Meg L, The George Institute for Global Health
local.contributor.affiliationHenderson, Seton J, Christchurch Hospital
local.contributor.affiliationMackle, Diane, Medical Research Institute of New Zealand
local.contributor.affiliationMcArthur, Colin, Medical Research Institute of New Zealand
local.contributor.affiliationMcGuinness, Shay P., Auckland City Hospital
local.contributor.affiliationMyburgh, John, George Institute for Global Health
local.contributor.affiliationSaxena, Manoj K, The George Institute for Global Health
local.contributor.affiliationTurner, Anne, Medical Research Institute of New Zealand
local.contributor.affiliationWebb, Steve AR, Royal Perth Hospital
local.contributor.affiliationBellomo, Rinaldo, Monash University
local.description.embargo2099-12-31
local.bibliographicCitation.issue1
local.bibliographicCitation.startpage81
local.bibliographicCitation.lastpage87
local.identifier.absseo920199 - Clinical Health (Organs, Diseases and Abnormal Conditions) not elsewhere classified
dc.date.updated2020-11-23T10:59:25Z
local.identifier.thomsonID000394920300013
CollectionsANU Research Publications

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