Department of Anesthesiology, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, No. 168 Litang Road, Beijing, 102218, China.
Department of Special Care Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100037, China.
Trials. 2023 Feb 1;24(1):72. doi: 10.1186/s13063-023-07073-x.
The high incidence of intraoperative glucose dysregulations in liver transplantation (LT) is related to the lack of highly orchestrated control of intraoperative blood glucose. Glucose monitoring based on a single arterial blood gas test can only provide a simple glucose profile and is insufficient in monitoring intraoperative glycemic variability (GV), which is not conducive to controlling GV and may have a lag in the management of hyper/hypoglycemia. Continuous glucose monitor (CGM), which has been successfully applied in the management of chronic disease in diabetes, provides more detailed blood glucose records and reflect GV parameters such as coefficient of variation (CV%). However, its effectiveness and accuracy for guiding blood glucose management in major surgeries remains unclear.
This is a single-center, randomized, controlled, superiority trial. One hundred and eighty patients scheduled for orthotopic LT will be recruited and randomized into two groups. All patients are monitored for intraoperative glucose using CGM combined with arterial blood gas (ABG). In the intervention group (group CG), ABG will be performed when CGM value is < 6.1 mmol/L or > 10.0 mmol/L, or the rate of change of CGM value > 1.67 mmol/(L·min). In the control group (group G), intraoperative ABG tests will be performed every 2 h, and the frequency of ABG tests will be adjusted based on the previous arterial glucose result. Patients in both groups will have their blood glucose adjusted according to arterial glucose values and a uniform protocol. Surgical and other anesthetic management is completed according to standard LT practices.
This study intends to investigate the effectiveness of CGM-based intraoperative glucose management and its impact on the prognosis of LT patients by comparing the GV, mean glucose values, and the incidence of hypo/hypoglycemic events guided by the above two glucose monitoring methods.
This study is registered at www.chictr.org.cn on January 4, 2022, under the registration number ChiCTR2200055236.
肝移植（LT）术中血糖失调发生率高，与术中血糖缺乏高度协调控制有关。基于单次动脉血气检测的血糖监测只能提供简单的血糖概况，不足以监测术中血糖变异性（GV），不利于控制 GV，并且在处理高/低血糖症时可能存在滞后。连续血糖监测（CGM）已成功应用于糖尿病的慢性病管理，提供更详细的血糖记录，并反映变异系数（CV%）等 GV 参数。然而，其在重大手术中指导血糖管理的有效性和准确性尚不清楚。
这是一项单中心、随机、对照、优效性试验。将招募并随机分为两组，共 180 例拟行原位 LT 的患者。所有患者均采用 CGM 联合动脉血气（ABG）监测术中血糖。在干预组（CG 组）中，当 CGM 值<6.1mmol/L 或>10.0mmol/L 或 CGM 值变化率>1.67mmol/（L·min）时，将进行 ABG 检测。在对照组（G 组）中，每 2h 进行一次术中 ABG 检测，并根据前一次动脉血糖结果调整 ABG 检测频率。两组患者均根据动脉血糖值和统一方案调整血糖。手术和其他麻醉管理按照标准 LT 实践进行。
本研究旨在通过比较两种血糖监测方法指导的 GV、平均血糖值以及低血糖/高血糖事件发生率，探讨 CGM 指导下的术中血糖管理的有效性及其对 LT 患者预后的影响。
本研究于 2022 年 1 月 4 日在中国临床试验注册中心（www.chictr.org.cn）注册，注册号 ChiCTR2200055236。
