Glucose-potassium-insulin infusions in the management of post-stroke hyperglycaemia: the UK Glucose Insulin in Stroke Trial (GIST-UK)
Glucose-potassium-insulin infusions in the management of post-stroke hyperglycaemia: the UK Glucose Insulin in Stroke Trial (GIST-UK)
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DOI：
10.1016/s1474-4422(07)70080-7
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发表时间：
2007-05-01
期刊：
影响因子：
48
通讯作者：
Alberti, K. George M. M.
中科院分区：
文献类型：
--
作者：
Gray, Christopher S.;Hildreth, Anthony J.;Alberti, K. George M. M.
背景：急性卒中后高血压是一种常见的发现，与死亡风险增加有关。我们试图确定在急性事件发生后立即输注葡萄糖钾胰岛素（GKI）以维持正常血糖是否会降低90天时的死亡率。方法将卒中发作24小时内入院血糖浓度在6.0-17.0 mmol/L之间的患者随机分配接受可变剂量胰岛素GKI治疗（干预）或生理盐水（对照）作为连续静脉内输注24 h。GKI输注的目的是将毛细血管葡萄糖维持在4-7 mmol/L，对照组不进行葡萄糖干预。主要终点是90天时的死亡，次要终点是90天时避免死亡或严重残疾。进行了额外的计划分析，以确定残留残疾或神经和功能恢复的任何差异。在5%的双侧显著性水平下，该试验具有83%的把握度来检测6%的死亡率差异（样本量2355）。这项研究被注册为国际标准随机对照试验（编号ISRCTN 31118803）。结果在招募了933名患者后，由于招募缓慢，试验停止。对于意向治疗数据，90天时死亡率无显著降低（GKI vs对照组：比值比1.14，95% CI 0.86.1.51，p=0.37）。次要结局无显著差异。在GKI组中，总体平均血糖和平均收缩压显著低于对照组（血糖平均差异为0.57 mmol/L，p < 0.001;血压平均差异为9.0 mmHg，p < 0.0001）。试验方案中的治疗与显著的临床获益无关，尽管该研究效力不足，不能排除其他结果。
Background Hyperglycaemia after acute stroke is a common finding that has been associated with an increased risk of death. We sought to determine whether treatment with glucose-potassium-insulin (GKI) infusions to maintain euglycaemia immediately after the acute event reduces death at 90 days.Methods Patients presenting within 24 h of stroke onset and with admission plasma glucose concentration between 6.0-17.0 mmol/L were randomly assigned to receive variable-dose-insulin GKI (intervention) or saline (control) as a continuous intravenous infusion for 24 h. The purpose of GKI infusion was to maintain capillary glucose at 4-7 mmol/L., with no glucose intervention in the control group. The primary outcome was death at 90 days, and the secondary endpoint was avoidance of death or severe disability at 90 days. Additional planned analyses were done to determine any differences in residual disability or neurological and functional recovery. The trial was powered to detect a mortality difference of 6% (sample size 2355), with 83% power, at the 5% two-sided significance level. This study is registered as an International Standard Randomised Controlled Trial (number ISRCTN 31118803)Findings The trial was stopped due to slow enrolment after 933 patients were recruited. For the intention-to-treat data, there was no significant reduction in mortality at 90 days (GKI vs control: odds ratio 1.14, 95% CI 0.86.1.51, p=0.37). There were no significant differences for secondary outcomes. In the GKI group, overall mean plasma glucose and mean systolic blood pressure were significantly lower than in the control group (mean difference in glucose 0.57 mmol/L, p < 0.001; mean difference in blood pressure 9.0 mmHg, p < 0.0001).Interpretation GKI infusions significantly reduced plasma glucose concentrations and blood pressure. Treatment within the trial protocol was not associated with significant clinical benefit, although the study was underpowered and alternative results cannot be excluded.