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Randomized Controlled Trial
Tight Blood-Glucose Control without Early Parenteral Nutrition in the ICU.
- Jan Gunst, Yves Debaveye, Fabian Güiza, Jasperina Dubois, Astrid De Bruyn, Dieter Dauwe, Erwin De Troy, Michael P Casaer, Greet De Vlieger, Renata Haghedooren, Bart Jacobs, Geert Meyfroidt, Catherine Ingels, Jan Muller, Dirk Vlasselaers, Lars Desmet, Liese Mebis, Pieter J Wouters, Björn Stessel, Laurien Geebelen, Jeroen Vandenbrande, Michiel Brands, Ine Gruyters, Ester Geerts, Ilse De Pauw, Joris Vermassen, Harlinde Peperstraete, Eric Hoste, Jan J De Waele, Ingrid Herck, Pieter Depuydt, Alexander Wilmer, Greet Hermans, Dominique D Benoit, Greet Van den Berghe, and TGC-Fast Collaborators.
- From the Clinical Department of Intensive Care Medicine (J.G., Y.D., F.G., A.D.B., D.D., E.D.T., M.P.C., G.D.V., R.H., B.J., G.M., C.I., J.M., D.V., L.D., L.M., P.J.W., G.V.B.) and the Medical Intensive Care Unit (A.W., G.H.), University Hospitals of KU Leuven, Leuven, the Department of Anesthesiology and Intensive Care Medicine, Jessa Hospital, Hasselt (J.D., B.S., L.G., J. Vandenbrande, M.B., I.G., E.G., I.D.P.), and the Department of Intensive Care Medicine, Ghent University Hospital, Ghent (J. Vermassen, H.P., E.H., J.J.D.W., I.H., P.D., D.D.B.) - all in Belgium.
- N. Engl. J. Med. 2023 Sep 28; 389 (13): 118011901180-1190.
BackgroundRandomized, controlled trials have shown both benefit and harm from tight blood-glucose control in patients in the intensive care unit (ICU). Variation in the use of early parenteral nutrition and in insulin-induced severe hypoglycemia might explain this inconsistency.MethodsWe randomly assigned patients, on ICU admission, to liberal glucose control (insulin initiated only when the blood-glucose level was >215 mg per deciliter [>11.9 mmol per liter]) or to tight glucose control (blood-glucose level targeted with the use of the LOGIC-Insulin algorithm at 80 to 110 mg per deciliter [4.4 to 6.1 mmol per liter]); parenteral nutrition was withheld in both groups for 1 week. Protocol adherence was determined according to glucose metrics. The primary outcome was the length of time that ICU care was needed, calculated on the basis of time to discharge alive from the ICU, with death accounted for as a competing risk; 90-day mortality was the safety outcome.ResultsOf 9230 patients who underwent randomization, 4622 were assigned to liberal glucose control and 4608 to tight glucose control. The median morning blood-glucose level was 140 mg per deciliter (interquartile range, 122 to 161) with liberal glucose control and 107 mg per deciliter (interquartile range, 98 to 117) with tight glucose control. Severe hypoglycemia occurred in 31 patients (0.7%) in the liberal-control group and 47 patients (1.0%) in the tight-control group. The length of time that ICU care was needed was similar in the two groups (hazard ratio for earlier discharge alive with tight glucose control, 1.00; 95% confidence interval, 0.96 to 1.04; P = 0.94). Mortality at 90 days was also similar (10.1% with liberal glucose control and 10.5% with tight glucose control, P = 0.51). Analyses of eight prespecified secondary outcomes suggested that the incidence of new infections, the duration of respiratory and hemodynamic support, the time to discharge alive from the hospital, and mortality in the ICU and hospital were similar in the two groups, whereas severe acute kidney injury and cholestatic liver dysfunction appeared less prevalent with tight glucose control.ConclusionsIn critically ill patients who were not receiving early parenteral nutrition, tight glucose control did not affect the length of time that ICU care was needed or mortality. (Funded by the Research Foundation-Flanders and others; TGC-Fast ClinicalTrials.gov number, NCT03665207.).Copyright © 2023 Massachusetts Medical Society.
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