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Control of hyperglycaemia in paediatric intensive care (CHiP): study protocol

Authors :
Percy Deborah
Snowdon Claire
Allen Elizabeth
Betts Helen
Truesdale Ann
Goldman Allan
Slavik Zdenek
Fortune Peter-Marc
Baines Paul
Schindler Margrid
Nadel Simon
Parslow Roger
Grieve Richard
Pappachan John
Macrae Duncan
Broadhead Michael
Quick Tara
Peters Mark
Morris Kevin
Tasker Robert
Elbourne Diana
Source :
BMC Pediatrics, Vol 10, Iss 1, p 5 (2010)
Publication Year :
2010
Publisher :
BMC, 2010.

Abstract

Abstract Background There is increasing evidence that tight blood glucose (BG) control improves outcomes in critically ill adults. Children show similar hyperglycaemic responses to surgery or critical illness. However it is not known whether tight control will benefit children given maturational differences and different disease spectrum. Methods/Design The study is an randomised open trial with two parallel groups to assess whether, for children undergoing intensive care in the UK aged ≤ 16 years who are ventilated, have an arterial line in-situ and are receiving vasoactive support following injury, major surgery or in association with critical illness in whom it is anticipated such treatment will be required to continue for at least 12 hours, tight control will increase the numbers of days alive and free of mechanical ventilation at 30 days, and lead to improvement in a range of complications associated with intensive care treatment and be cost effective. Children in the tight control group will receive insulin by intravenous infusion titrated to maintain BG between 4 and 7.0 mmol/l. Children in the control group will be treated according to a standard current approach to BG management. Children will be followed up to determine vital status and healthcare resources usage between discharge and 12 months post-randomisation. Information regarding overall health status, global neurological outcome, attention and behavioural status will be sought from a subgroup with traumatic brain injury (TBI). A difference of 2 days in the number of ventilator-free days within the first 30 days post-randomisation is considered clinically important. Conservatively assuming a standard deviation of a week across both trial arms, a type I error of 1% (2-sided test), and allowing for non-compliance, a total sample size of 1000 patients would have 90% power to detect this difference. To detect effect differences between cardiac and non-cardiac patients, a target sample size of 1500 is required. An economic evaluation will assess whether the costs of achieving tight BG control are justified by subsequent reductions in hospitalisation costs. Discussion The relevance of tight glycaemic control in this population needs to be assessed formally before being accepted into standard practice. Trial Registration Current Controlled Trials ISRCTN61735247

Subjects

Subjects :
Pediatrics
RJ1-570

Details

Language :
English
ISSN :
14712431
Volume :
10
Issue :
1
Database :
Directory of Open Access Journals
Journal :
BMC Pediatrics
Publication Type :
Academic Journal
Accession number :
edsdoj.b5820278ccb4a82a183ca65e7cb9d95
Document Type :
article
Full Text :
https://doi.org/10.1186/1471-2431-10-5