Specialty: Children, Primary sub-specialty: Allergy, Infection and Immunity
Conditions
Interventions
Current interventions as of 04/05/2018:
The trial incorporates a pragmatic approach to temperature control in both the permissive group and restrictive group.
Permissive group: Treatments to reduce
Sponsors
Intensive Care National Audit And Research Centre (ICNARC)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of parents/legal representatives refusing deferred consent is measured as the proportion of recruited children whose parents subsequently declined to give consent or who withdrew their child from the Fever Pilot Trial having initially given consent through study complete (an average of 24 hours) 2. The acceptability of the information and documentation and of the consenting procedures is measured using the survey responses from parents who gave and declined to give consent; and qualitative evaluation of telephone interview transcripts from interviews with parents who gave and declined to give consent at study complete (an average of 24 hours) 3. Adherence to the selected temperature thresholds for antipyretic intervention in both the higher temperature threshold (intervention) and standard care groups is measured as the proportion of time spent below the allocated threshold; and the proportion of children that received antipyretic intervention on days when their maximum temperature did not reach the allocated threshold; and the proportion of children that did not receive antipyretic intervention on days when their maximum temperature exceeded the allocated threshold at six hourly observations of temperature and antipyretic use over the first seven days as well as daily maximum peak temperature until 28 days. 4. Separation between the randomised groups in peak temperature measurement over the first 48 hours following randomisation is assessed as the difference in the mean of the maximum temperature recorded during the first 48 hours following randomisation between the higher temperature threshold and standard care groups, presented with a 95% confidence interval at baseline 5. Length of ventilation and Length of PICU stay is measured as the proportion of randomised patients with outcome available in each group, mean (standard deviation) in each group, median and quartiles in each group at study completion (an average 2 days) 6. PICU mortality is measure | — |
Countries
England, United Kingdom
Contacts
Public ContactImran Khan
Outcome results
None listed