Fever Observational Study

• Conditions: Fever

• Registration Number: NCT03028818
• Lead Sponsor: Intensive Care National Audit & Research Centre

Brief Summary

To inform the feasibility of conducting a study to test different temperature thresholds at which clinicians deliver interventions to reduce fever (i.e. antipyretic interventions) in critically ill children with fever due to infection.

Detailed Description

Fever (high temperature) is a normal bodily response to an infection, which has shown to have a beneficial effect in humans with chickenpox, malaria and rhinovirus infections. In children it has been recommended by the National Institute for Health and Care Excellence not to cool down the child using drugs or physical methods such as a cooling mat, with the sole aim to reducing the child's temperature. However, this recommendation is not aimed at the management of critically ill children, to which there is uncertainty around use of cooling interventions when considering the advantages of a fever in defending the body against viruses and bacteria during critical illness, and weighing that up with the possible negative physiological consequences of a high fever e.g. increased metabolic rate.

Observational studies show that the treatment of fever in critically ill children is inconsistent. There is a lack of robust data to guide antipyretic intervention, with clinicians usually starting fever management at around 37.5°C. Evidence is emerging that fever may be beneficial in critically ill adults. Due to the physiological differences between adults and children there is an important need to evaluate whether a different approach to fever management in critically ill children may also be beneficial.

Prior to conducting a large, expensive, randomised clinical trial (RCT) to evaluate whether a higher temperature threshold in starting treatments to cool down the child would be beneficial, we are conducting three studies to know if it is possible for us to test key outcome measures as a result of testing different temperatures thresholds for antipyretic management.

The Fever Observational Study is one of these studies, with the aim of identifying: the potential population that would be eligible for the proposed definitive trial, current temperature threshold(s) for fever management, and to describe the characteristics of outcome measures with the intention of deciding on a main measure to see which treatment method was more successful.

Study Timeline

• Status Verified: 2017-01
• Study First Submitted: 2017-01-13
• Study First Submitted QC: 2017-01-19
• Last Update Submitted: 2017-01-19
• Study First Posted: 2017-01-23
• Last Update Posted: 2017-01-23
• Study Start: 2017-02
• Primary Completion: 2017-07
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3960

Inclusion Criteria

unplanned PICU admission referral requiring PICU admission to a participating unit

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Temperature thresholds currently employed in at least 20 paediatric intensive care units (PICU) in the UK	First 5 calender days
Length of PICU stay - mean (standard deviation)	Through study completion, an average of 2 days
Days of organ specific support - mean (standard deviation)	Through study completion, an average of 2 days
PICU mortality - number (percentage)	Through study completion, an average of 2 days
To determine the number of patients who meet the eligibility criteria for a proposed definitive trial.	Baseline
Length of ventilation - mean (standard deviation)	Through study completion, an average of 2 days
Hospital mortality - number (percentage)	Through study completion, an average of 2 days

Trial Locations

Locations (1)

Intensive Care National Audit and Research Centre; 🇬🇧 London, United Kingdom