Fever pilot trial

Not Applicable

Completed

• Conditions: Specialty: Children, Primary sub-specialty: Allergy, Infection and Immunity; UKCRC code/ Disease: Infection/ Other viral diseases; Infections and Infestations; Allergy, Infection and Immunity

• Registration Number: ISRCTN16022198
• Lead Sponsor: Intensive Care National Audit And Research Centre (ICNARC)

Brief Summary

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30793698 results (added 25/02/2019) 2022 Protocol article in https://journals.lww.com/pccmjournal/Fulltext/9900/Protocol_for_a_Randomized_Multiple_Center_Trial_of.49.aspx (added 12/08/2022) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/30845977/ Permissive versus restrictive temperature thresholds (added 20/09/2023) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33692177/ acceptability findings (added 20/09/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-14
• Study Completion: 2018-04-13
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

Current inclusion criteria as of 04/05/2018:
1. Unplanned PICU admission
2. Age = 28 days and < 16 years
3. Referral requiring PICU admission to a participating unit
4. Fever = 37.5°C in the first 48 hours following contact with the paediatric retrieval service/PICU
5. New requirement for mechanical ventilation
6. Treating clinician presumes the cause of the fever is an infective process

Previous inclusion criteria:
1. Unplanned PICU admission
2. Age = 28 days and < 16 years
3. Referral requiring PICU admission to a participating unit
4. Fever = 37.5°C in the first 48 hours following contact with the paediatric retrieval service/PICU
5. Receiving or requiring mechanical ventilation
6. Treating clinician presumes the cause of the fever is an infective process

Exclusion Criteria

Current exclusion criteria as of 04/05/2018:
1. Acute encephalopathy, including convulsive status epilepticus
2. Post-cardiopulmonary bypass or known/suspected cardiomyopathy/myocarditis
3. Rhabdomyolysis
4. Malignant hyperthermia, neuroleptic malignant syndrome or drug-induced hyperthermia
5. Receiving palliative care or death perceived as imminent
6. Previously recruited to the Fever Pilot Trial

Previous exclusion criteria:
1. Acute encephalopathy, including convulsive status epilepticus
2. Post-cardiopulmonary bypass or known/suspected cardiomyopathy/myocarditis
3. Severe rhabdomyolysis
4. Sickle cell disease
5. Malignant hyperthermia, neuroleptic malignant syndrome or drug-induced hyperthermia
6. Receiving palliative care or death perceived as imminent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of eligible patients recruited per site, per month is measured using the proportion of eligible children recorded in trial screening logs that were recruited to the Fever Pilot Trial at baseline