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.

中文翻译：

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危重患者的个体化与常规血糖控制：控制研究——一项随机临床试验

目的

高血糖是危重疾病中常见的对压力的适应性反应。它的管理在重症监护病房（ICU）中仍然存在争议。通过针对患者入院前的正常血糖进行个体化的高血糖管理，可以改善结果。

方法

在一项多中心、随机、双盲、平行组研究中，考虑纳入危重成人。患者在 ICU 出院前接受个体化血糖控制，即通过使用 ICU 入院时的糖化血红蛋白 A1c 水平来控制入院前的正常血糖（IC 组），或通过将血糖维持在 180 mg/dL 以下进行常规血糖控制（CC 组）。动态滑动规模胰岛素协议的非商业网络应用程序向护士提供了两组血糖控制的所有指示。主要结局是 90 天内死亡。

结果

由于受益的可能性很低，并且有证据表明低血糖可能造成伤害，因此该研究提前停止。2075 名患者被随机分配；1917 人接受了干预，IC 组 942 人，CC 组 975 人。尽管两组在血糖控制方面存在显着差异，但 90 天的存活率没有显着差异（IC 组：67.2%，95% CI [64.2%；70.3%]；CC 组：69.6%，95% CI [ 66.7%；72.5%]）。IC 组 3.9% 的患者和 CC 组 2.5% 的患者出现严重低血糖（低于 40 mg/dL）（p  = 0.09）。事后分析显示，与 CC 组相比，IC 组的非糖尿病患者 90 天死亡风险更高（HR 1.3, 95% CI [1.05; 1.59], p  = 0.018）。

结论

与将血糖维持在 180 mg/dL 以下相比，使用动态滑动量表胰岛素方案针对 ICU 患者入院前的正常血糖并没有显示出生存益处。