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

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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 A. R.
dc.contributor.authorBellomo, Rinaldo
dc.date.accessioned2021-02-05T00:46:23Z
dc.date.issued2017
dc.date.updated2020-11-02T04:26:22Z
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.en_AU
dc.description.sponsorshipFunded 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.en_AU
dc.format.mimetypeapplication/pdfen_AU
dc.identifier.issn1441-2772en_AU
dc.identifier.urihttp://hdl.handle.net/1885/222051
dc.language.isoen_AUen_AU
dc.publisherAustralasian Academy of Critical Care Medicineen_AU
dc.rights© 2017 Critical Care and Resuscitationen_AU
dc.sourceCritical Care and Resuscitationen_AU
dc.source.urihttps://ccr.cicm.org.au/file/download-article?id=7ac40f0a-c5a1-4c87-90fe-34a465d3e157&settings=litnzgC1RAsiHS43rCo4xm8sTGX%2FtNDM%2BDTnf0aDZAg%3Den_AU
dc.titleProtocol and statistical analysis plan for the Randomised Evaluation of Active Control of Temperature versus Ordinary Temperature Management (REACTOR) trialen_AU
dc.typeJournal articleen_AU
dcterms.accessRightsOpen Access via publisher siteen_AU
local.bibliographicCitation.issue1en_AU
local.bibliographicCitation.lastpage87en_AU
local.bibliographicCitation.startpage81en_AU
local.contributor.affiliationYoung, Paul, Wellington Regional Hospitalen_AU
local.contributor.affiliationBailey, Michael, Monash Universityen_AU
local.contributor.affiliationBeasley, Richard W., Medical Research Institute of New Zealanden_AU
local.contributor.affiliationFreebairn, Ross, Medical Research Institute of New Zealanden_AU
local.contributor.affiliationHammond, Naomi, George Institute for Global Healthen_AU
local.contributor.affiliationVan Haren, Frank, College of Health and Medicine, ANUen_AU
local.contributor.affiliationHarward, Meg L., The George Institute for Global Healthen_AU
local.contributor.affiliationHenderson, Seton J., Christchurch Hospitaen_AU
local.contributor.affiliationMackle, Diane, Medical Research Institute of New Zealanden_AU
local.contributor.affiliationMcArthur, Colin, Medical Research Institute of New Zealanden_AU
local.contributor.affiliationMcGuinness, Shay P., Auckland City Hospitalen_AU
local.contributor.affiliationMyburgh, John, George Institute for Global Healthen_AU
local.contributor.affiliationSaxena, Manoj K., The George Institute for Global Healthen_AU
local.contributor.affiliationTurner, Anne, Medical Research Institute of New Zealanden_AU
local.contributor.affiliationWebb, Steve A. R., Royal Perth Hospitalen_AU
local.contributor.affiliationBellomo, Rinaldo, Monash Universityen_AU
local.contributor.authoremailu5325459@anu.edu.auen_AU
local.contributor.authoruidVan Haren, Frank, u5325459en_AU
local.description.embargo2099-12-31
local.description.notesImported from ARIESen_AU
local.identifier.absfor110310 - Intensive Careen_AU
local.identifier.absseo920199 - Clinical Health (Organs, Diseases and Abnormal Conditions) not elsewhere classifieden_AU
local.identifier.ariespublicationu6048437xPUB432en_AU
local.identifier.citationvolume19en_AU
local.identifier.thomsonID000394920300013
local.identifier.uidSubmittedByu6048437en_AU
local.publisher.urlhttps://ccr.cicm.org.au/en_AU
local.type.statusPublished Versionen_AU

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