用于重症监护患者血糖控制的太空葡萄糖控制系统——一项欧洲多中心观察性研究。
Space GlucoseControl system for blood glucose control in intensive care patients--a European multicentre observational study.
作者信息
Blaha Jan, Barteczko-Grajek Barbara, Berezowicz Pawel, Charvat Jiri, Chvojka Jiri, Grau Teodoro, Holmgren Jonathan, Jaschinski Ulrich, Kopecky Petr, Manak Jan, Moehl Mette, Paddle Jonathan, Pasculli Marcello, Petersson Johan, Petros Sirak, Radrizzani Danilo, Singh Vinodkumar, Starkopf Joel
机构信息
Department of Anaesthesiology and Intensive Medicine, 1st Faculty of Medicine, Charles University and General University Hospital Prague, U Nemocnice 2, 128 08, Prague 2, Czech Republic.
Department of Anaesthesiology and Intensive Therapy, Wroclaw Medical University, Wroclaw, Poland.
出版信息
BMC Anesthesiol. 2016 Jan 22;16:8. doi: 10.1186/s12871-016-0175-4.
BACKGROUND
Glycaemia control (GC) remains an important therapeutic goal in critically ill patients. The enhanced Model Predictive Control (eMPC) algorithm, which models the behaviour of blood glucose (BG) and insulin sensitivity in individual ICU patients with variable blood samples, is an effective, clinically proven computer based protocol successfully tested at multiple institutions on medical and surgical patients with different nutritional protocols. eMPC has been integrated into the B.Braun Space GlucoseControl system (SGC), which allows direct data communication between pumps and microprocessor. The present study was undertaken to assess the clinical performance and safety of the SGC for glycaemia control in critically ill patients under routine conditions in different ICU settings and with various nutritional protocols.
METHODS
The study endpoints were the percentage of time the BG was within the target range 4.4 - 8.3 mmol.l(-1), the frequency of hypoglycaemic episodes, adherence to the advice of the SGC and BG measurement intervals. BG was monitored, and insulin was given as a continuous infusion according to the advice of the SGC. Nutritional management (enteral, parenteral or both) was carried out at the discretion of each centre.
RESULTS
17 centres from 9 European countries included a total of 508 patients, the median study time was 2.9 (1.9-6.1) days. The median (IQR) time-in-target was 83.0 (68.7-93.1) % of time with the mean proposed measurement interval 2.0 ± 0.5 hours. 99.6% of the SGC advices on insulin infusion rate were accepted by the user. Only 4 episodes (0.01% of all BG measurements) of severe hypoglycaemia <2.2 mmol.l(-1) in 4 patients occurred (0.8%; 95% CI 0.02-1.6%).
CONCLUSION
Under routine conditions and under different nutritional protocols the Space GlucoseControl system with integrated eMPC algorithm has exhibited its suitability for glycaemia control in critically ill patients.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01523665.
背景
血糖控制（GC）仍然是重症患者重要的治疗目标。增强型模型预测控制（eMPC）算法通过对不同血样的个体重症监护病房（ICU）患者的血糖（BG）行为和胰岛素敏感性进行建模，是一种有效的、经临床验证的基于计算机的方案，已在多家机构针对采用不同营养方案的内科和外科患者成功进行了测试。eMPC已集成到贝朗太空血糖控制系统（SGC）中，该系统允许泵与微处理器之间进行直接数据通信。本研究旨在评估SGC在不同ICU环境下的常规条件下以及采用各种营养方案时对重症患者进行血糖控制的临床性能和安全性。
方法
研究终点为血糖处于4.4 - 8.3 mmol·L⁻¹目标范围内的时间百分比、低血糖发作频率、对SGC建议的依从性以及血糖测量间隔。监测血糖，并根据SGC的建议持续输注胰岛素。各中心自行决定营养管理方式（肠内、肠外或两者结合）。
结果
来自9个欧洲国家的17个中心共纳入508例患者，中位研究时间为2.9（1.9 - 6.1）天。中位（四分位间距）目标时间为83.0（68.7 - 93.1）%，平均建议测量间隔为2.0 ± 0.5小时。用户接受了99.6%的SGC关于胰岛素输注速率的建议。仅4例患者发生了4次严重低血糖事件（<2.2 mmol·L⁻¹，占所有血糖测量的比例为0.01%）（0.8%；95%置信区间0.02 - 1.6%）。
结论
在常规条件下以及采用不同营养方案时，集成了eMPC算法的太空血糖控制系统已显示出其对重症患者血糖控制的适用性。
试验注册
ClinicalTrials.gov NCT01523665
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