Please use this identifier to cite or link to this item: http://hdl.handle.net/2381/44492
Title: Permissive versus restrictive temperature thresholds in critically ill children with fever and infection: a multicentre randomized clinical pilot trial.
Authors: Peters, MJ
Woolfall, K
Khan, I
Deja, E
Mouncey, PR
Wulff, J
Mason, A
Agbeko, RS
Draper, ES
Fenn, B
Gould, DW
Koelewyn, A
Klein, N
Mackerness, C
Martin, S
O'Neill, L
Ray, S
Ramnarayan, P
Tibby, S
Thorburn, K
Tume, L
Watkins, J
Wellman, P
Harrison, DA
Rowan, KM
FEVER Investigators on behalf of the Paediatric Intensive Care Society Study Group (PICS-SG)
First Published: 7-Mar-2019
Publisher: BMC (part of Springer Nature), Critical Care Canada Forum (CCCF), International Symposium on Intensive Care and Emergency Medicine (ISICEM)
Citation: Critical Care, 2019, 23:69
Abstract: BACKGROUND: Fever improves pathogen control at a significant metabolic cost. No randomized clinical trials (RCT) have compared fever treatment thresholds in critically ill children. We performed a pilot RCT to determine whether a definitive trial of a permissive approach to fever in comparison to current restrictive practice is feasible in critically ill children with suspected infection. METHODS: An open, parallel-group pilot RCT with embedded mixed methods perspectives study in four UK paediatric intensive care units (PICUs) and associated retrieval services. Participants were emergency PICU admissions aged > 28 days to < 16 years receiving respiratory support and supplemental oxygen. Subjects were randomly assigned to permissive (antipyretic interventions only at ≥ 39.5 °C) or restrictive groups (antipyretic interventions at ≥ 37.5 °C) whilst on respiratory support. Parents were invited to complete a questionnaire or take part in an interview. Focus groups were conducted with staff at each unit. Outcomes were measures of feasibility: recruitment rate, protocol adherence and acceptability, between group separation of temperature and safety. RESULTS: One hundred thirty-eight children met eligibility criteria of whom 100 (72%) were randomized (11.1 patients per month per site) without prior consent (RWPC). Consent to continue in the trial was obtained in 87 cases (87%). The mean maximum temperature (95% confidence interval) over the first 48 h was 38.4 °C (38.2-38.6) in the restrictive group and 38.8 °C (38.6-39.1) in the permissive group, a mean difference of 0.5 °C (0.2-0.8). Protocol deviations were observed in 6.8% (99/1438) of 6-h time periods and largely related to patient comfort in the recovery phase. Length of stay, duration of organ support and mortality were similar between groups. No pre-specified serious adverse events occurred. Staff (n = 48) and parents (n = 60) were supportive of the trial, including RWPC. Suggestions were made to only include invasively ventilated children for the duration of intubation. CONCLUSION: Uncertainty around the optimal fever threshold for antipyretic intervention is relevant to many emergency PICU admissions. A more permissive approach was associated with a modest increase in mean maximum temperature. A definitive trial should focus on the most seriously ill cases in whom antipyretics are rarely used for their analgesic effects alone. TRIAL REGISTRATION: ISRCTN16022198 . Registered on 14 August 2017.
DOI Link: 10.1186/s13054-019-2354-4
eISSN: 1466-609X
Links: https://ccforum.biomedcentral.com/articles/10.1186/s13054-019-2354-4
http://hdl.handle.net/2381/44492
Version: Publisher Version
Status: Peer-reviewed
Type: Journal Article
Rights: Copyright © the authors, 2019. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Description: All data generated and/or analysed during this study are included in this published article (and its supplementary information files) and the study monograph available in the HTA Journal (currently in press).
Appears in Collections:Published Articles, Dept. of Health Sciences



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