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

Macrae, D; Pappachan, J; Grieve, R; Parslow, R; Nadel, S; Schindler, M; Baines, P; ... Elbourne, D; + view all (2010) Control of hyperglycaemia in paediatric intensive care (CHiP): study protocol. BMC Pediatrics , 10 , Article 5. 10.1186/1471-2431-10-5. Green open access

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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 <or= 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.

Type: Article
Title: Control of hyperglycaemia in paediatric intensive care (CHiP): study protocol
Open access status: An open access version is available from UCL Discovery
DOI: 10.1186/1471-2431-10-5
Publisher version: http://dx.doi.org/10.1186/1471-2431-10-5
Language: English
Additional information: © 2010 Macrae et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Keywords: Adolescent, Age, Child, Preschool child, Clinical protocols, Critical illness, Drug monitoring, Hyperglycemia, Blood, Therapy, Epidemiology, Etiology, Infant, Newborn infant, Infusions, Intravenous, Insulin administration, Insulin dosage, Insulin, therapeutic use, Pediatric Intensive Care Unit, Patient selection, Postoperative complications, Research design, Artificial respiration, Treatment outcome, Vasoconstrictor agents, Ventilator weaning
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health > Infection, Immunity and Inflammation Dept
URI: https://discovery.ucl.ac.uk/id/eprint/1330640
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