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首页> 外文会议>IFAC Symposium on Biological and Medical Systems >Preliminary results from the STAR-Liege clinical trial: Virtual trials, safety, performance, and compliance analysis
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Preliminary results from the STAR-Liege clinical trial: Virtual trials, safety, performance, and compliance analysis

机译：星列临床试验中的初步结果：虚拟试验，安全，性能和合规分析

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Glycaemic control has been shown to improve outcome in critically ill patients, but hard to achieve in a safe and effective manner. This paper presents the preliminary results of 8 patients controlled at the University Hospital of Liege under STAR-Liege, an insulin-only version of the model-based STAR glycaemic controller framework. Clinical data is compared with virtual trial simulations of the glycaemic control outcomes for the STAR-Liege protocol, and with the standard of care protocol of this intensive care unit, to assess safety, performance, and compliance of the new protocol. Results show 78% of clinical blood glucose measurements in target band. Only 3% of blood glucose measurements were below 4.4 mmol/L (79 mg/dL), with only 1% mild hypoglycaemia and no severe hypoglycaemia. These results are similar to simulation of the protocol, but slightly higher workload is observed clinically due to nursing choice. Compared to standard protocol virtual trial simulations, STAR-Liege achieved tighter and less variable control with similar safety, and less percentage time in higher blood glucose levels. Clinically, 14% of insulin intervention were increased or decreased from recommendation with median [IQR] change of 1 or -2 [-3, -2] U/hr respectively. Clinical and simulation results show STAR-Liege better controls glycaemia to lower ranges compared to the standard protocol, while ensuring safety. Lower time in higher blood glucose ranges potentially improves patient outcomes. Compliance analysis shows potential nurse fears in protocol changes and different insulin dosing. These results are encouraging for the continuation of the clinical trial realised in this medical intensive care unit and its extension to insulin and nutrition control.
机译：血糖控制已被证明可以改善危重患者的预后，但很难在一个安全和有效的方式来实现。本文介绍了在烈日下STAR-列日，基于模型的STAR血糖控制框架的胰岛素唯一版本的大学医院控制8名患者的初步结果。临床数据与用于STAR-列日协议的血糖控制的结果的虚拟试验模拟进行比较，以及与此重症监护病房的护理方案的标准，来评估安全性，性能和新协议的遵从性。结果表明在目标频带临床血液葡萄糖测量的78％。只有3％的血糖测量的低于4.4毫摩尔/ L（79毫克/分升），只有1％的轻度的低血糖和无严重低血糖。这些结果是类似的协议的仿真，但稍微高工作量由于护理选择临床上观察到的。相比标准协议虚拟试验模拟，STAR-列日实现了与相似的安全性更紧密的和更少的可变控制，并且在更高的血糖水平较少百分比的时间。在临床上，胰岛素干预的14％的增加或从建议降低分别为1位[IQR]变化或-2 [-3，-2] U /小时。临床和实验结果表明STAR-列日更好控制血糖降低的范围相对于标准协议，同时确保安全性。下一次在较高的血糖范围可能改善患者的预后。合规性分析表明，协议的变化和不同的胰岛素剂量潜在护士的恐惧。这些结果是令人鼓舞的临床试验在这内科重症监护单元及其扩展胰岛素和营养控制实现的延续。

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