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Tight glycaemic control in critically ill children

Tight glycaemic control in critically ill children. Introduction.

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Tight glycaemic control in critically ill children

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  1. Tight glycaemic control in critically ill children

  2. Introduction • The Control of Hyperglycaemia in Paediatric Intensive Care (CHiP) trial had the ambitious goal to assess in multiple centres whether ‘tight glycaemic control’ (TGC) with insulin titrated to a blood glucose target of 4.0–7.0 mmol/l reduces morbidity and mortality of critically ill children in a cost-effective manner compared with tolerating blood glucose levels up to 12.0 mmol/l • The primary end point was the number of days alive and free from ventilator support assessed within 30 days of randomization. This primary end point was unaffected by whether or not the patient was under TGC

  3. Introduction • However, TGC did limit the incidence of kidney failure, reduce the total duration of hospital stay from a mean of 29 days to 24 days and lower health-care costs by a mean of US$5,847 • To understand these results and how they might differ from those of the first randomized controlled trial on TGC in critically ill children (henceforth referred to as the Belgian study), several aspects of the CHiP trial design should be considered • These include the chosen target ranges for blood glucose; the anticipated effect size and statistical power; and the time window during which the primary outcome was assessed

  4. Methods • Macrae and colleagues hypothesized that hyperglycaemia during critical illness in children causes harm • To test this hypothesis, children in the control group should have hyperglycaemia and those in the intervention group should be treated to achieve normoglycaemia • Although these terms have been widely used, the definitions of hyperglycaemia and normoglycaemia vary substantially

  5. Methods • In the CHiP trial, hyperglycaemia was defined as blood glucose levels >7.0 mmol/l, as the target range for TGC in the intervention arm was set at 4.0–7.0 mmol/l. This target range was assumed to reflect normoglycaemia in children • Macrae and co-workers also assumed that children in the control group would all have blood glucose concentrations >7.0 mmol/l. • By comparison, the Belgian study defined normoglycaemia on the normal fasting ranges for blood glucose: 2.8–4.4 mmol/l for infants (<1 year) & 3.9–5.6 mmol/l for children (≥1 year)

  6. Findings • The Belgian study showed that targeting such lower ranges for blood levels of glucose reduced morbidity and mortality, and improved long-term neurocognitive development • Both studies included similar proportions of infants and of patients undergoing cardiac surgery • The Belgian study included somewhat more severely ill patients than the CHiP trial (as indicated by the paediatric logistic organ dysfunction score being three points higher on admission and a higher baseline blood level of glucose)

  7. Findings • In the CHiP trial, about half of the children in the control group were already in the normoglycaemia range without insulin treatment (day 1 blood levels of glucose 6.7 mmol/l and settling at ~6.3 mmol/l thereafter) • The finding that only 66% of patients in the intervention group required insulin at any time further supported this assertion • In addition, the Belgian study had previously shown that when left untreated, critically ill children spontaneously settled at blood glucose levels of ~6.4 mmol/l

  8. Findings • Hence, from the choice of the target levels in the intervention arm of the CHiP trial, it could have been anticipated that the results in the patients on TGC would hardly differ from those of the comparator group. Indeed, TGC in CHiP reduced the mean blood levels of glucose by just 0.4 mmol/l • As point-of-care blood glucose meters can have a total analytical error of 10%,8 the overall difference in blood glucose was smaller than the assay error, which could call into the question the clinical relevance of these findings

  9. Different outcomes related to levels of TGC in the CHiP and Belgian trials • In the Belgian study, the difference between the two groups was 1.7 mmol/l, which might explain the stronger findings

  10. Future Implications • Several issues need to be addressed in future studies. For example, consensus definitions of hyperglycaemia and normoglycaemia, specifically for the paediatric population, should be based on observational studies in healthy & critically ill children • Furthermore, multicentre clinical studies should be performed that target ‘true’ normoglycaemia, which is then compared with a strategy of avoiding any insulin administration in a large population of patients at risk of pronounced and sustained hyperglycaemia

  11. Conclusion • Lowering blood glucose concentrations in critically ill children at risk of pronounced and sustained hyperglycaemia seems to generate a dose-dependent benefit on outcomes • Even a quite conservative target range shortened the duration of hospital stay and reduced health-care costs in the CHiP trial • Future studies should include a larger sample size or only select patients with hyperglycaemia and extend the follow-up for the primary end point analysis far beyond the first 30 days

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