A multi-centre randomised, parallel group pilot clinical trial investigating the feasibility of a definitive trial of a permissive temperature strategy in critically ill children with known or suspected infection

Intensive Care National Audit And Research Centre (ICNARC)0 个研究点目标入组 205 人开始时间: 2017年8月14日最近更新: 2023年10月3日

适应症

试验速览

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)

•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

•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

发起方

Intensive Care National Audit And Research Centre (ICNARC)