TY - JOUR
T1 - Tight blood-glucose control without early parenteral nutrition in the ICU
AU - TGC-Fast Collaborators
AU - Gunst, Jan
AU - Debaveye, Yves
AU - Güiza, Fabian
AU - Dubois, Jasperina
AU - De Bruyn, Astrid
AU - Dauwe, Dieter
AU - De Troy, Erwin
AU - Casaer, Michael P
AU - De Vlieger, Greet
AU - Haghedooren, Renata
AU - Jacobs, Bart
AU - Meyfroidt, Geert
AU - Ingels, Catherine
AU - Muller, Jan
AU - Vlasselaers, Dirk
AU - Desmet, Lars
AU - Mebis, Liese
AU - Wouters, Pieter J
AU - Stessel, Björn
AU - Geebelen, Laurien
AU - Vandenbrande, Jeroen
AU - Brands, Michiel
AU - Gruyters, Ine
AU - Geerts, Ester
AU - De Pauw, Ilse
AU - Vermassen, Joris
AU - Peperstraete, Harlinde
AU - Hoste, Eric
AU - De Waele, Jan J
AU - Herck, Ingrid
AU - Depuydt, Pieter
AU - Wilmer, Alexander
AU - Hermans, Greet
AU - Benoit, Dominique D
AU - Van den Berghe, Greet
N1 - NPP
PY - 2023
Y1 - 2023
N2 - BACKGROUND: Randomized, 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.METHODS: We 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.RESULTS: Of 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.CONCLUSIONS: In 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.).
AB - BACKGROUND: Randomized, 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.METHODS: We 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.RESULTS: Of 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.CONCLUSIONS: In 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.).
KW - Humans
KW - Blood Glucose/analysis
KW - Glucose/analysis
KW - Hypoglycemia/chemically induced
KW - Insulin/administration & dosage
KW - Intensive Care Units
KW - Glycemic Control/adverse effects
KW - Parenteral Nutrition
KW - Algorithms
KW - Critical Illness/therapy
U2 - 10.1056/NEJMoa2304855
DO - 10.1056/NEJMoa2304855
M3 - A1: Web of Science-article
C2 - 37754283
SN - 0028-4793
VL - 389
SP - 1180
EP - 1190
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 13
ER -