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Control of hyperglycaemia in paediatric intensive care (CHiP): study protocol |
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| Authors: | Duncan Macrae John Pappachan Richard Grieve Roger Parslow Simon Nadel Margrid Schindler Paul Baines Peter-Marc Fortune Zdenek Slavik Allan Goldman Ann Truesdale Helen Betts Elizabeth Allen Claire Snowdon Deborah Percy Michael Broadhead Tara Quick Mark Peters Kevin Morris Robert Tasker Diana Elbourne |
| Affiliation: | 1. Paediatric Intensive Care Unit, Royal Brompton Hospital, Sydney Street, London, SW3 6NP, UK 2. Paediatric Intensive Care Unit, Southampton University Hospitals NHS Trust, Tremona Road, Southampton, SO16 6YD, UK 3. Health Services Research Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK 4. Paediatric Epidemiology Group Centre for Epidemiology & Biostatistics, 8,49 Worsley Building University of Leeds, Leeds, LS2 9JT, UK 5. Paediatric Intensive Care Unit, Imperial Healthcare NHS Trust, St Mary's Hospital, London, WC2, UK 6. Paediatric Intensive Care Unit, Bristol Royal Hospital for Children, Bristol, BS2 8BJ, UK 7. Paediatric Intensive Care Unit, Alder Hey Children's Hospital, Eaton Rd, Liverpool, L12 2AP, UK 8. Paediatric Intensive Care Unit, Royal Manchester Children's Hospital, Hospital Road, Pendlebury, Manchester, M27 4HA, UK 9. Royal Brompton Hospital, Sydney Street, London, SW3 6NP, UK 10. Cardiac Intensive Care Unit, Great Ormond Street Children's Hospital, London, WC1 3JH, UK 11. Medical Statistics Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK 12. Paediatric Intensive Care Unit, Royal Brompton Hospital, Sydney Street, London, SW3 6NP, UK 13. Medical Statistics Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK 14. London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK 15. Medical Statistics Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK 16. Great Ormond Street Children's Hospital, London, WC1N 3JH, UK 17. Parent, c/o London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK 18. Paediatric Intensive Care Unit, Great Ormond Street Children's Hospital, London, WC1N 3JH, UK 19. Paediatric Intensive Care Unit, Birmingham Children's Hospital NHS Foundation Trust, Steelhouse Lane, Birmingham, B46NH, UK 20. Department of Paediatrics, University of Cambridge, Cambridge, B2 0QQ, UK 21. Medical Statistics Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK |
| Abstract: | BackgroundThere 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/DesignThe 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.DiscussionThe relevance of tight glycaemic control in this population needs to be assessed formally before being accepted into standard practice.Trial RegistrationCurrent Controlled Trials ISRCTN61735247 |
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