Permissive versus restrictive temperature thresholds in critically ill children with fever and infection: a multicentre randomized clinical pilot trial
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 cur...
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| Published in | Critical care (London, England) Vol. 23; no. 1; pp. 69 - 11 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
London
BioMed Central
07.03.2019
BioMed Central Ltd BMC |
| Subjects | |
| Online Access | Get full text |
| ISSN | 1364-8535 1466-609X 1364-8535 1466-609X |
| DOI | 10.1186/s13054-019-2354-4 |
Cover
| 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. |
|---|---|
| AbstractList | 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 [greater than or equai to] 39.5 [degrees]C) or restrictive groups (antipyretic interventions at [greater than or equai to] 37.5 [degrees]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 [degrees]C (38.2-38.6) in the restrictive group and 38.8 [degrees]C (38.6-39.1) in the permissive group, a mean difference of 0.5 [degrees]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. Keywords: Sepsis, Infection, Paediatric intensive care, Fever, Paracetamol, Antipyretics, Clinical trial 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. 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. 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. 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. ISRCTN16022198 . Registered on 14 August 2017. 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.BACKGROUNDFever 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.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.METHODSAn 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.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.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.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.CONCLUSIONUncertainty 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.ISRCTN16022198 . Registered on 14 August 2017.TRIAL REGISTRATIONISRCTN16022198 . Registered on 14 August 2017. 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. 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. An open, parallel-group pilot RCT with embedded mixed methods perspectives study in four UK paediatric intensive care units (PICUs) and associated retrieval services. Subjects were randomly assigned to permissive (antipyretic interventions only at [greater than or equai to] 39.5 [degrees]C) or restrictive groups (antipyretic interventions at [greater than or equai to] 37.5 [degrees]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. 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 [degrees]C (38.2-38.6) in the restrictive group and 38.8 [degrees]C (38.6-39.1) in the permissive group, a mean difference of 0.5 [degrees]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. 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. 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. |
| ArticleNumber | 69 |
| Audience | Academic |
| Author | Thorburn, Kentigern Agbeko, Rachel S. Gould, Doug W. Fenn, Blaise Koelewyn, Abby Tume, Lyvonne Deja, Elisabeth Tibby, Shane Mouncey, Paul R. Wulff, Jerome Draper, Elizabeth S. Harrison, David A. Khan, Imran Mason, Alexina Ray, Samiran Peters, Mark J. Ramnarayan, Padmanabhan Martin, Sian Klein, Nigel Watkins, Jason O’Neill, Lauran Woolfall, Kerry Mackerness, Christine Wellman, Paul Rowan, Kathryn M. |
| Author_xml | – sequence: 1 givenname: Mark J. orcidid: 0000-0003-3653-4808 surname: Peters fullname: Peters, Mark J. email: mark.peters@ucl.ac.uk organization: Respiratory, Critical Care and Anaesthesia Unit, Paediatric Intensive Care, UCL Great Ormond Street Institute of Child Health, Paediatric Intensive Care Unit, Great Ormond Street Hospital for Children NHS Foundation Trust – sequence: 2 givenname: Kerry surname: Woolfall fullname: Woolfall, Kerry organization: Department of Psychological Sciences, North West Hub for Trials Methodology, University of Liverpool – sequence: 3 givenname: Imran surname: Khan fullname: Khan, Imran organization: Clinical Trials Unit, Intensive Care National Audit and Research Centre – sequence: 4 givenname: Elisabeth surname: Deja fullname: Deja, Elisabeth organization: Department of Psychological Sciences, North West Hub for Trials Methodology, University of Liverpool – sequence: 5 givenname: Paul R. surname: Mouncey fullname: Mouncey, Paul R. organization: Clinical Trials Unit, Intensive Care National Audit and Research Centre – sequence: 6 givenname: Jerome surname: Wulff fullname: Wulff, Jerome organization: Clinical Trials Unit, Intensive Care National Audit and Research Centre – sequence: 7 givenname: Alexina surname: Mason fullname: Mason, Alexina organization: Clinical Trials Unit, Intensive Care National Audit and Research Centre – sequence: 8 givenname: Rachel S. surname: Agbeko fullname: Agbeko, Rachel S. organization: NHS Foundation Trust, Institute of Cellular Medicine, Newcastle University – sequence: 9 givenname: Elizabeth S. surname: Draper fullname: Draper, Elizabeth S. organization: Department of Health Sciences, University of Leicester – sequence: 10 givenname: Blaise surname: Fenn fullname: Fenn, Blaise organization: Patient and Parent representative – sequence: 11 givenname: Doug W. surname: Gould fullname: Gould, Doug W. organization: Clinical Trials Unit, Intensive Care National Audit and Research Centre – sequence: 12 givenname: Abby surname: Koelewyn fullname: Koelewyn, Abby organization: Clinical Trials Unit, Intensive Care National Audit and Research Centre – sequence: 13 givenname: Nigel surname: Klein fullname: Klein, Nigel organization: Infection, Inflammation and Rheumatology, UCL Great Ormond Street Institute of Child Health – sequence: 14 givenname: Christine surname: Mackerness fullname: Mackerness, Christine organization: NHS Foundation Trust – sequence: 15 givenname: Sian surname: Martin fullname: Martin, Sian organization: Clinical Trials Unit, Intensive Care National Audit and Research Centre – sequence: 16 givenname: Lauran surname: O’Neill fullname: O’Neill, Lauran organization: Paediatric Intensive Care Unit, Great Ormond Street Hospital for Children NHS Foundation Trust – sequence: 17 givenname: Samiran surname: Ray fullname: Ray, Samiran organization: Respiratory, Critical Care and Anaesthesia Unit, Paediatric Intensive Care, UCL Great Ormond Street Institute of Child Health, Paediatric Intensive Care Unit, Great Ormond Street Hospital for Children NHS Foundation Trust – sequence: 18 givenname: Padmanabhan surname: Ramnarayan fullname: Ramnarayan, Padmanabhan organization: Respiratory, Critical Care and Anaesthesia Unit, Paediatric Intensive Care, UCL Great Ormond Street Institute of Child Health, Children’s Acute Transport Service, Great Ormond Street Hospital for Children NHS Foundation Trust – sequence: 19 givenname: Shane surname: Tibby fullname: Tibby, Shane organization: Evelina Children’s Hospital, Guy’s and St Thomas’ NHS Foundation Trust – sequence: 20 givenname: Kentigern surname: Thorburn fullname: Thorburn, Kentigern organization: Alder Hey Children’s Hospital NHS Foundation Trust – sequence: 21 givenname: Lyvonne surname: Tume fullname: Tume, Lyvonne organization: Faculty of Health and Applied Sciences, University of the West of England – sequence: 22 givenname: Jason surname: Watkins fullname: Watkins, Jason organization: Institute of Cellular Medicine, Newcastle University – sequence: 23 givenname: Paul surname: Wellman fullname: Wellman, Paul organization: Evelina Children’s Hospital, Guy’s and St Thomas’ NHS Foundation Trust – sequence: 24 givenname: David A. surname: Harrison fullname: Harrison, David A. organization: Clinical Trials Unit, Intensive Care National Audit and Research Centre – sequence: 25 givenname: Kathryn M. surname: Rowan fullname: Rowan, Kathryn M. organization: Clinical Trials Unit, Intensive Care National Audit and Research Centre |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/30845977$$D View this record in MEDLINE/PubMed |
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| Keywords | Infection Paracetamol Sepsis Clinical trial Paediatric intensive care Fever Antipyretics |
| Language | English |
| License | Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
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Fever improves pathogen control at a significant metabolic cost. No randomized clinical trials (RCT) have compared fever treatment thresholds in... Fever improves pathogen control at a significant metabolic cost. No randomized clinical trials (RCT) have compared fever treatment thresholds in critically ill... Background Fever improves pathogen control at a significant metabolic cost. No randomized clinical trials (RCT) have compared fever treatment thresholds in... Abstract Background Fever improves pathogen control at a significant metabolic cost. No randomized clinical trials (RCT) have compared fever treatment... |
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| SubjectTerms | Antipyretics Care and treatment Child Child, Preschool Childhood fever Children Clinical trials Critical Care Medicine Critical Illness - therapy Emergency Medicine Female Fever Fever - etiology Fever - physiopathology Focus Groups - methods Humans Infant Infection Infections - complications Infections - physiopathology Intensive Intensive Care Units, Pediatric - organization & administration Intensive Care Units, Pediatric - statistics & numerical data Male Medicine Medicine & Public Health Mortality Paediatric intensive care Paracetamol Patient outcomes Pediatric intensive care Pediatrics Pilot Projects Sepsis Surveys and Questionnaires Threshold Limit Values Treatment Outcome United Kingdom |
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