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):1180-1190. doi: 10.1056/NEJMoa2304855.
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.
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.
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.
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.).
随机对照试验表明，在重症监护病房（ICU）的患者中，严格的血糖控制既有益处，也有危害。早期肠外营养的使用和胰岛素引起的严重低血糖的差异可能解释了这种不一致性。
我们在 ICU 入院时将患者随机分配到宽松血糖控制组（仅在血糖水平>215mg/dL[>11.9mmol/L]时开始使用胰岛素）或严格血糖控制组（使用 LOGIC-Insulin 算法将血糖水平目标设定为 80-110mg/dL[4.4-6.1mmol/L]）；两组均在 1 周内停止肠外营养。根据血糖指标确定方案的依从性。主要结局是 ICU 护理所需的时间，基于从 ICU 出院时的存活时间计算，死亡被视为竞争风险；90 天死亡率是安全性结局。
在 9230 名接受随机分组的患者中，4622 名患者被分配到宽松血糖控制组，4608 名患者被分配到严格血糖控制组。宽松血糖控制组的清晨血糖水平中位数为 140mg/dL（四分位距，122-161），严格血糖控制组为 107mg/dL（四分位距，98-117）。宽松血糖控制组有 31 名（0.7%）患者发生严重低血糖，严格血糖控制组有 47 名（1.0%）患者发生严重低血糖。两组 ICU 护理所需的时间相似（严格血糖控制组提前出院的风险比为 1.00；95%置信区间，0.96 至 1.04；P=0.94）。90 天死亡率也相似（宽松血糖控制组为 10.1%，严格血糖控制组为 10.5%，P=0.51）。八项预设次要结局的分析表明，两组新发感染的发生率、呼吸和血流动力学支持的持续时间、从医院出院的时间、ICU 和医院的死亡率以及急性肾损伤和胆汁淤积性肝功能障碍的发生率均相似，而严格血糖控制组似乎较少出现严重急性肾损伤和胆汁淤积性肝功能障碍。
在未接受早期肠外营养的危重症患者中，严格的血糖控制并未影响 ICU 护理所需的时间或死亡率。（由研究基金会-佛兰德斯和其他机构资助；TGC-Fast 临床试验.gov 编号，NCT03665207）。
