Luckraz Heyman, Giri Ramesh, Wrigley Benjamin, Nagarajan Kumaresan, Senanayake Eshan, Sharman Emma, Beare Lawrence, Nevill Alan
Cardiothoracic Surgeon, American Hospital, Dubai, United Arab Emirates.
Cardiothoracic Anaesthesiologist, Heart and Lung Centre, Wolverhampton, UK.
Eur J Cardiothorac Surg. 2021 Apr 13;59(3):562-569. doi: 10.1093/ejcts/ezaa395.
Our goal was to investigate the efficacy of balanced forced diuresis in reducing the rate of acute kidney injury (AKI) in cardiac surgical patients requiring cardiopulmonary bypass (CPB), using the RenalGuard® (RG) system.
Patients at risk of developing AKI (history of diabetes and/or anaemia; estimated glomerular filtration rate 20-60 ml/min/1.73 m2; anticipated CPB time >120 min; log EuroSCORE > 5) were randomized to the RG system group (n = 110) or managed according to current practice (control = 110). The primary end point was the development of AKI within the first 3 postoperative days as defined by the RIFLE (Risk, Injury, Failure, Loss of kidney function, End-stage renal disease) criteria.
There were no significant differences in preoperative and intraoperative characteristics between the 2 groups. Postoperative AKI rates were significantly lower in the RG system group compared to the control group [10% (11/110) vs 20.9% (23/110); P = 0.025]. This effect persisted even after controlling for a number of potential confounders (odds ratio 2.82, 95% confidence interval 1.20-6.60; P = 0.017) when assessed by binary logistic regression analysis. The mean volumes of urine produced during surgery and within the first 24 h postoperatively were significantly higher in the RG system group (P < 0.001). There were no significant differences in the incidence of blood transfusions, atrial fibrillation and infections and in the median duration of intensive care unit stays between the groups. The number needed to treat with the RG system to prevent AKI was 9 patients (95% confidence interval 6.0-19.2).
In patients at risk for AKI who had cardiac surgery with CPB, the RS RG system significantly reduced the incidence of AKI and can be used safely and reproducibly. Larger studies are required to confirm cost benefits.
NCT02974946.
我们的目标是使用RenalGuard®（RG）系统，研究平衡强制利尿在降低需要体外循环（CPB）的心脏手术患者急性肾损伤（AKI）发生率方面的疗效。
有发生AKI风险的患者（糖尿病和/或贫血病史；估计肾小球滤过率20 - 60 ml/min/1.73 m²；预期CPB时间>120 min；欧洲心脏手术风险评估系统（EuroSCORE）评分>5）被随机分为RG系统组（n = 110）或按照当前实践进行管理（对照组 = 110）。主要终点是术后第1个3天内按照RIFLE（风险、损伤、衰竭、肾功能丧失、终末期肾病）标准定义的AKI发生情况。
两组患者术前和术中特征无显著差异。与对照组相比，RG系统组术后AKI发生率显著更低[10%（11/110）对20.9%（23/110）；P = 0.025]。通过二元逻辑回归分析评估时，即使在控制了多个潜在混杂因素后，这种效果仍然存在（比值比为2.82，95%置信区间为1.20 - 6.60；P = 0.017）。RG系统组手术期间及术后最初24小时内产生的平均尿量显著更高（P < 0.001）。两组之间输血、房颤和感染的发生率以及重症监护病房住院时间中位数无显著差异。使用RG系统预防AKI所需治疗的患者数为9例（95%置信区间为6.0 - 19.2）。
在接受CPB心脏手术且有AKI风险的患者中，RS RG系统显著降低了AKI的发生率，并且可以安全、重复地使用。需要更大规模的研究来证实成本效益。
NCT02974946。
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