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Individualised versus conventional glucose control in critically-ill patients: the CONTROLING study-a randomized clinical trial.

Julien Bohé 1, 2 Hassane Abidi 1, 2 Vincent Brunot 3 Amna Klich 2, 4 Kada Klouche 5, 6 Nicholas Sedillot 7 Xavier Tchenio 7 Jean-Pierre Quenot 8, 9, 10, 11, 12 Jean-Baptiste Roudaut 8 Nicolas Mottard 1, 2 Fabrice Thiollière 1, 2 Jean Dellamonica 13, 14 Florent Wallet 1, 2 Bertrand Souweine 15, 16 Alexandre Lautrette 15, 16 Jean-Charles Preiser 17 Jean-François Timsit 18, 19 Charles-Hervé Vacheron 1, 2 Ali Ait Hssain 15 Delphine Maucort-Boulch 2, 4
Abstract : Purpose: Hyperglycaemia is an adaptive response to stress commonly observed in critical illness. Its management remains debated in the intensive care unit (ICU). Individualising hyperglycaemia management, by targeting the patient's pre-admission usual glycaemia, could improve outcome. Methods: In a multicentre, randomized, double-blind, parallel-group study, critically-ill adults were considered for inclusion. Patients underwent until ICU discharge either individualised glucose control by targeting the pre-admission usual glycaemia using the glycated haemoglobin A1c level at ICU admission (IC group), or conventional glucose control by maintaining glycaemia below 180 mg/dL (CC group). A non-commercial web application of a dynamic sliding-scale insulin protocol gave to nurses all instructions for glucose control in both groups. The primary outcome was death within 90 days. Results: Owing to a low likelihood of benefit and evidence of the possibility of harm related to hypoglycaemia, the study was stopped early. 2075 patients were randomized; 1917 received the intervention, 942 in the IC group and 975 in the CC group. Although both groups showed significant differences in terms of glycaemic control, survival probability at 90-day was not significantly different (IC group: 67.2%, 95% CI [64.2%; 70.3%]; CC group: 69.6%, 95% CI [66.7%; 72.5%]). Severe hypoglycaemia (below 40 mg/dL) occurred in 3.9% of patients in the IC group and in 2.5% of patients in the CC group (p = 0.09). A post hoc analysis showed for non-diabetic patients a higher risk of 90-day mortality in the IC group compared to the CC group (HR 1.3, 95% CI [1.05; 1.59], p = 0.018). Conclusion: Targeting an ICU patient's pre-admission usual glycaemia using a dynamic sliding-scale insulin protocol did not demonstrate a survival benefit compared to maintaining glycaemia below 180 mg/dL.
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Submitted on : Saturday, October 2, 2021 - 7:01:40 PM
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2021 Bohé et al., Individuali...
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Julien Bohé, Hassane Abidi, Vincent Brunot, Amna Klich, Kada Klouche, et al.. Individualised versus conventional glucose control in critically-ill patients: the CONTROLING study-a randomized clinical trial.. Intensive Care Medicine, Springer Verlag, 2021, ⟨10.1007/s00134-021-06526-8⟩. ⟨hal-03363013⟩



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