Dataset Information

Permissive versus restrictive temperature thresholds in critically ill children with fever and infection: a multicentre randomized clinical pilot trial.

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 ResultsOne 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.

SUBMITTER: Peters MJ

PROVIDER: S-EPMC6407208 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Permissive versus restrictive temperature thresholds in critically ill children with fever and infection: a multicentre randomized clinical pilot trial.

Peters Mark J MJ Woolfall Kerry K Khan Imran I Deja Elisabeth E Mouncey Paul R PR Wulff Jerome J Mason Alexina A Agbeko Rachel S RS Draper Elizabeth S ES Fenn Blaise B Gould Doug W DW Koelewyn Abby A Klein Nigel N Mackerness Christine C Martin Sian S O'Neill Lauran L Ray Samiran S Ramnarayan Padmanabhan P Tibby Shane S Thorburn Kentigern K Tume Lyvonne L Watkins Jason J Wellman Paul P Harrison David A DA Rowan Kathryn M KM

Critical care (London, England) 20190307 1

<h4>Background</h4>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.<h4>Methods</h4>An open, parallel-group pilot RCT with embedded mixed methods perspectives study in fo ...[more]

PMID: 30845977

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Project description:BACKGROUND:In the critically ill, energy delivery from enteral nutrition (EN) is often less than the estimated energy requirement. Parenteral nutrition (PN) as a supplement to EN may increase energy delivery. We aimed to determine if an individually titrated supplemental PN strategy commenced 48-72 hours following ICU admission and continued for up to 7 days would increase energy delivery to critically ill adults compared to usual care EN delivery. METHODS:This study was a prospective, parallel group, phase II pilot trial conducted in six intensive care units in Australia and New Zealand. Mechanically ventilated adults with at least one organ failure and EN delivery below 80% of estimated energy requirement in the previous 24 hours received either a supplemental PN strategy (intervention group) or usual care EN delivery. EN in the usual care group could be supplemented with PN if EN remained insufficient after usual methods to optimise delivery were attempted. RESULTS:There were 100 patients included in the study and 99 analysed. Overall, 71% of the study population were male, with a mean (SD) age of 59 (17) years, Acute Physiology and Chronic Health Evaluation II score of 18.2 (6.7) and body mass index of 29.6 (5.8) kg/m2. Significantly greater energy (mean (SD) 1712 (511) calories vs. 1130 (601) calories, p?<?0.0001) and proportion of estimated energy requirement (mean (SD) 83 (25) % vs. 53 (29) %, p?<?0.0001) from EN and/or PN was delivered to the intervention group compared to usual care. Delivery of protein and proportion of estimated protein requirements were also greater in the intervention group (mean (SD) 86 (25) g, 86 (23) %) compared to usual care (mean (SD) 53 (29) g, 51 (25) %, p?<?0.0001). Antibiotic use, ICU and hospital length of stay, mortality and functional outcomes were similar between the two groups. CONCLUSIONS:This individually titrated supplemental PN strategy applied over 7 days significantly increased energy delivery when compared to usual care delivery. Clinical and functional outcomes were similar between the two patient groups. TRIAL REGISTRATION:Clinical Trial registry details: NCT01847534 (First registered 22 April 2013, last updated 31 July 2016).

Dataset Information

Permissive versus restrictive temperature thresholds in critically ill children with fever and infection: a multicentre randomized clinical pilot trial.

Background

Methods

Conclusion

Trial registration

Publications

Permissive versus restrictive temperature thresholds in critically ill children with fever and infection: a multicentre randomized clinical pilot trial.

Similar Datasets

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