Paul J Young1,2, Michael J Bailey3, Frances Bass4,5, Richard W Beasley6, Ross C Freebairn6,7, Naomi E Hammond4,5, Frank M P van Haren8,9,10, Meg L Harward4, Seton J Henderson11, Diane M Mackle6, Colin J McArthur6,12, Shay P McGuinness6,13, John A Myburgh4, Manoj K Saxena4,14, Anne M Turner6, Steve A R Webb3,15,16, Rinaldo Bellomo3,17. 1. Intensive Care Unit, Wellington Regional Hospital, Wellington, New Zealand. paul.young@ccdhb.org.nz. 2. Medical Research Institute of New Zealand, Wellington, New Zealand. paul.young@ccdhb.org.nz. 3. Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia. 4. Critical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia. 5. Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital, St Leonards, NSW, Australia. 6. Medical Research Institute of New Zealand, Wellington, New Zealand. 7. Intensive Care Unit, Hawke's Bay Hospital, Hastings, New Zealand. 8. Intensive Care Unit, The Canberra Hospital, Canberra, ACT, Australia. 9. School of Medicine, Australian National University, Canberra, ACT, Australia. 10. Faculty of Health, University of Canberra, Canberra, ACT, Australia. 11. Intensive Care Unit, Christchurch Hospital, Christchurch, New Zealand. 12. Department of Critical Care Medicine, Auckland City Hospital, Auckland, New Zealand. 13. Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland, New Zealand. 14. Intensive Care Unit, Bankstown Hospital, Sydney, NSW, Australia. 15. Intensive Care Unit, Royal Perth Hospital, Perth, WA, Australia. 16. School of Medicine and Pharmacology, University of Western Australia, Crawley, WA, Australia. 17. Intensive Care Unit, Austin Hospital, Melbourne, VIC, Australia.
Abstract
PURPOSE: It is unknown whether protocols targeting systematic prevention and treatment of fever achieve lower mean body temperature than usual care in intensive care unit (ICU) patients. The objective of the Randomised Evaluation of Active Control of temperature vs. ORdinary temperature management trial was to confirm the feasibility of such a protocol with a view to conducting a larger trial. METHODS: We randomly assigned 184 adults without acute brain pathologies who had a fever in the previous 12 h, and were expected to be ventilated beyond the calendar day after recruitment, to systematic prevention and treatment of fever or usual care. The primary outcome was mean body temperature in the ICU within 7 days of randomisation. Secondary outcomes included in-hospital mortality, ICU-free days and survival time censored at hospital discharge. RESULTS: Compared with usual temperature management, active management significantly reduced mean temperature. In both groups, fever generally abated within 72 h. The mean temperature difference between groups was greatest in the first 48 h, when it was generally in the order of 0.5 °C. Overall, 23 of 89 patients assigned to active management (25.8%) and 23 of 89 patients assigned to usual management (25.8%) died in hospital (odds ratio 1.0, 95% CI 0.51-1.96, P = 1.0). There were no statistically significant differences between groups in ICU-free days or survival to day 90. CONCLUSIONS: Active temperature management reduced body temperature compared with usual care; however, fever abated rapidly, even in patients assigned to usual care, and the magnitude of temperature separation was small. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry Number, ACTRN12616001285448.
RCT Entities:
PURPOSE: It is unknown whether protocols targeting systematic prevention and treatment of fever achieve lower mean body temperature than usual care in intensive care unit (ICU) patients. The objective of the Randomised Evaluation of Active Control of temperature vs. ORdinary temperature management trial was to confirm the feasibility of such a protocol with a view to conducting a larger trial. METHODS: We randomly assigned 184 adults without acute brain pathologies who had a fever in the previous 12 h, and were expected to be ventilated beyond the calendar day after recruitment, to systematic prevention and treatment of fever or usual care. The primary outcome was mean body temperature in the ICU within 7 days of randomisation. Secondary outcomes included in-hospital mortality, ICU-free days and survival time censored at hospital discharge. RESULTS: Compared with usual temperature management, active management significantly reduced mean temperature. In both groups, fever generally abated within 72 h. The mean temperature difference between groups was greatest in the first 48 h, when it was generally in the order of 0.5 °C. Overall, 23 of 89 patients assigned to active management (25.8%) and 23 of 89 patients assigned to usual management (25.8%) died in hospital (odds ratio 1.0, 95% CI 0.51-1.96, P = 1.0). There were no statistically significant differences between groups in ICU-free days or survival to day 90. CONCLUSIONS: Active temperature management reduced body temperature compared with usual care; however, fever abated rapidly, even in patients assigned to usual care, and the magnitude of temperature separation was small. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry Number, ACTRN12616001285448.
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