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
Highlights
There is increasing evidence that tight blood glucose (BG) control improves outcomes in critically ill adults
The ability to control blood sugar is known to be impaired in patients subjected to the stress of major surgery or critical illness resulting in high blood sugar levels[1]
This study demonstrated that hyperglycaemia is common among critically ill children
Summary
There is increasing evidence that tight blood glucose (BG) control improves outcomes in critically ill adults. The ability to control blood sugar is known to be impaired in patients subjected to the stress of major surgery or critical illness resulting in high blood sugar levels (hyperglycaemia)[1]. This may in part result from insulin resistance, as insulin-dependent glucose uptake has been shown to be reduced in various organs and tissues during critical illness. Glucose uptake is increased in non-insulin dependent tissues such as brain, red blood cells and wounds This imbalance of glucose metabolism has previously been interpreted as the body’s plea for tolerating moderately high levels of glucose during critical illness and injury and treatment of ‘stress-induced’ hyperglycaemia has typically only been initiated if BG levels are persistently and substantially elevated. Gastrointestinal effects Hyperglycaemia has been shown to be associated with delayed gastric emptying[10], decreased small bowel motility and to increase sensation and cerebral evoked potentials to a range of gastrointestinal stimuli in adult volunteers [11,12,13,14]
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