Protocol and statistical analysis plan for the randomised evaluation of active control of temperature versus ordinary temperature management (REACTOR) trial

Paul J Young, Michael J. Bailey, Richard W Beasley, Ross C Freebairn, Naomi E Hammond, Frank M P Van Haren, Meg L. Harward, Seton J Henderson, Diane M. Mackle, Colin J. McArthur, Shay P. McGuinness, John A. Myburgh, Manoj K Saxena, Anne Turner, Steve A.R. Webb, Rinaldo Bellomo, The ANZICS Clinical Trials Group

Research output: Contribution to journalArticleOtherpeer-review

5 Citations (Scopus)

Abstract

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 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.

Original languageEnglish
Pages (from-to)81-87
Number of pages7
JournalCritical Care and Resuscitation
Volume19
Issue number1
Publication statusPublished - 2017

Cite this

Young, P. J., Bailey, M. J., Beasley, R. W., Freebairn, R. C., Hammond, N. E., Van Haren, F. M. P., ... The ANZICS Clinical Trials Group (2017). Protocol and statistical analysis plan for the randomised evaluation of active control of temperature versus ordinary temperature management (REACTOR) trial. Critical Care and Resuscitation, 19(1), 81-87.
Young, Paul J ; Bailey, Michael J. ; Beasley, Richard W ; Freebairn, Ross C ; Hammond, Naomi E ; Van Haren, Frank M P ; 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 ; The ANZICS Clinical Trials Group. / Protocol and statistical analysis plan for the randomised evaluation of active control of temperature versus ordinary temperature management (REACTOR) trial. In: Critical Care and Resuscitation. 2017 ; Vol. 19, No. 1. pp. 81-87.
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title = "Protocol and statistical analysis plan for the randomised evaluation of active control of temperature versus ordinary temperature management (REACTOR) trial",
abstract = "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 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.",
author = "Young, {Paul J} and Bailey, {Michael J.} and Beasley, {Richard W} and Freebairn, {Ross C} and Hammond, {Naomi E} and {Van Haren}, {Frank M P} and Harward, {Meg L.} and Henderson, {Seton J} and Mackle, {Diane M.} and McArthur, {Colin J.} and McGuinness, {Shay P.} and Myburgh, {John A.} and Saxena, {Manoj K} and Anne Turner and Webb, {Steve A.R.} and Rinaldo Bellomo and {The ANZICS Clinical Trials Group}",
year = "2017",
language = "English",
volume = "19",
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issn = "1441-2772",
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Young, PJ, Bailey, MJ, Beasley, RW, Freebairn, RC, Hammond, NE, Van Haren, FMP, Harward, ML, Henderson, SJ, Mackle, DM, McArthur, CJ, McGuinness, SP, Myburgh, JA, Saxena, MK, Turner, A, Webb, SAR, Bellomo, R & The ANZICS Clinical Trials Group 2017, 'Protocol and statistical analysis plan for the randomised evaluation of active control of temperature versus ordinary temperature management (REACTOR) trial', Critical Care and Resuscitation, vol. 19, no. 1, pp. 81-87.

Protocol and statistical analysis plan for the randomised evaluation of active control of temperature versus ordinary temperature management (REACTOR) trial. / Young, Paul J; Bailey, Michael J.; Beasley, Richard W; Freebairn, Ross C; Hammond, Naomi E; Van Haren, Frank M P; 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; The ANZICS Clinical Trials Group.

In: Critical Care and Resuscitation, Vol. 19, No. 1, 2017, p. 81-87.

Research output: Contribution to journalArticleOtherpeer-review

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T1 - Protocol and statistical analysis plan for the randomised evaluation of active control of temperature versus ordinary temperature management (REACTOR) trial

AU - Young, Paul J

AU - Bailey, Michael J.

AU - Beasley, Richard W

AU - Freebairn, Ross C

AU - Hammond, Naomi E

AU - Van Haren, Frank M P

AU - Harward, Meg L.

AU - Henderson, Seton J

AU - Mackle, Diane M.

AU - McArthur, Colin J.

AU - McGuinness, Shay P.

AU - Myburgh, John A.

AU - Saxena, Manoj K

AU - Turner, Anne

AU - Webb, Steve A.R.

AU - Bellomo, Rinaldo

AU - The ANZICS Clinical Trials Group

PY - 2017

Y1 - 2017

N2 - 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 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.

AB - 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 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.

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M3 - Article

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JF - Critical Care and Resuscitation

SN - 1441-2772

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