A Clinical and Economic Evaluation of Control of Hyperglycaemia in Paediatric Intensive Care: The CHiP Randomised Controlled Trial

• Published in: Health technology assessment (Winchester, England) England), 2014-04, Vol.18 (26), p.240 pages-240 pages
• Main Authors: Macrae, Duncan, Grieve, Richard, Allen, Elizabeth, Sadique, Zia, Betts, Helen, Morris, Kevin, Pappachan, Vithayathil John, Parslow, Roger, Tasker, Robert C, Baines, Paul, Broadhead, Michael, Duthie, Mark L, tune, Peter-Marc, Inwald, David, McMaster, Paddy, Peters, Mark J, Schindler, Margrid, Guerriero, Carla, Piercy, Deborah, Slavik, Zdenek, Snowdon, Claire, Van Dyck, Laura, Elbourne, Diana
• Format: Article
• Language: English
• ISSN: 1366-5278
• DOI: 10.3310/hta18260

Background: Early research in adults admitted to intensive care suggested that tight control of blood glucose during acute illness can be associated with reductions in mortality, length of hospital stay and complications such as infection and renal failure. Prior to our study, it was unclear whether or not children could also benefit from tight control of blood glucose during critical illness. Objectives: This study aimed to determine if controlling blood glucose using insulin in paediatric intensive care units (PICUs) reduces mortality and morbidity and is cost-effective, whether or not admission follows cardiac surgery. Design: Randomised open two-arm parallel group superiority design with central randomisation with minimisation. Analysis was on an intention-to-treat basis. Following random allocation, care givers and outcome assessors were no longer blind to allocation. Setting: The setting was 13 English PICUs. Participants: Patients who met the following criteria were eligible for inclusion: ? 36 weeks corrected gestational age; ? 16 years; in the PICU following injury, following major surgery or with critical illness; anticipated treatment > 12 hours; arterial line; mechanical ventilation; and vasoactive drugs. Exclusion criteria were as follows: diabetes mellitus; inborn error of metabolism; treatment withdrawal considered; in the PICU > 5 consecutive days; and already in CHiP (Control of Hyperglycaemia in Paediatric intensive care). Intervention: The intervention was tight glycaemic control (TGC): insulin by intravenous infusion titrated to maintain blood glucose between 4.0 and 7.0 mmol/l. Conventional management (CM): This consisted of insulin by intravenous infusion only if blood glucose exceeded 12.0 mmol/l on two samples at least 30 minutes apart; insulin was stopped when blood glucose fell below 10.0 mmol/l. Main outcome measures: The primary outcome was the number of days alive and free from mechanical ventilation within 30 days of trial entry (VFD-30). The secondary outcomes comprised clinical and economic outcomes at 30 days and 12 months and lifetime cost-effectiveness, which included costs per quality-adjusted life-year. Results: CHiP recruited from May 2008 to September 2011. In total, 19,924 children were screened and 1369 eligible patients were randomised (TGC, 694; CM, 675), 60% of whom were in the cardiac surgery stratum. The randomised groups were comparable at trial entry. More children in the TGC than in the CM arm received insul