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Cyclosporine before Coronary Artery Bypass Grafting Does Not Prevent Postoperative Decreases in Renal Function: A Randomized Clinical Trial
背景与目的
急性肾损伤是心脏手术后常见的并发症，导致发病率和死亡率增加。急性肾损伤的一个原因是体外循环引起的缺血再灌注损伤。在动物实验中，环孢霉素已被证实能减少肾脏的缺血再灌注损伤。我们假设体外循环前给予环孢霉素可以保护心脏手术患者的肾脏。
方 法
环孢素在心脏手术中保护肾功能（ciprics）研究是一项双盲、随机、研究者发起的，安慰剂对照的单中心研究。主要目的是评估环孢霉素是否能减少体外循环冠状动脉旁路移植术患者的急性肾损伤。在这项研究中，纳入154例肾小球滤过率15至90 ml·min–1·1.73m–2患者。患者被随机分配手术前接受2.5 mg/kg环孢素或安慰剂静脉注射。主要终点为术前至术后第3天血浆胱抑素C的相对变化。次要终点包括肾脏、心脏和脑损伤的生物标志物。
结 果
对所有入选患者进行分析。与安慰剂组相比（115.9 ± 30.8%），环孢素组（136.4 ± 35.6%）显示至术后第三天与基线相比血浆胱抑素C 3明显的增加，差值20.6%（95% CI，10.2至31.2%，P＜0.001）。其他肾脏标记物也观察到相同的模式。环孢菌素组有更多的患者出现危险性损伤、失败、终末期（RIFLE）组（风险）、I（损伤）、F（失败；31% vs 8%、p＜0.001）。各组间安全参数分布无差异。
结 论
环孢霉素对冠状动脉旁路移植术患者急性肾损伤无保护作用。相反，1个月后，环孢霉素组与安慰剂组相比，肾功能下降。
原始文献摘要
Ederoth P, Dardashti A, Grins E, et al. Cyclosporine before Coronary Artery Bypass Grafting Does Not Prevent Postoperative Decreases in Renal Function: A Randomized Clinical Trial[J]. Anesthesiology, 2018:1.
Background: Acute kidney injury is a common complication after cardiac surgery, leading to increased morbidity and mortality. One suggested cause for acute kidney injury is extracorporeal circulation–induced ischemia–reperfusion injury. In animal studies, cyclosporine has been shown to reduce ischemia–reperfusion injury in the kidneys. We hypothesized that administering cyclosporine before extracorporeal circulation could protect the kidneys in patients undergoing cardiac surgery.
Methods: The Cyclosporine to Protect Renal Function in Cardiac Surgery (CiPRICS) study was an investigator-initiated, double-blind, randomized, placebo-controlled, single-center study. The primary objective was to assess if cyclosporine could reduce acute kidney injury in patients undergoing coronary artery bypass grafting surgery with extracorporeal circulation. In the study, 154 patients with an estimated glomerular filtration rate of 15 to 90 ml · min–1 · 1.73 m–2 were enrolled. Study patients were randomized to receive 2.5 mg/kg cyclosporine or placebo intravenously before surgery. The primary endpoint was relative plasma cystatin C changes from the preoperative day to postoperative day 3. Secondary endpoints included biomarkers of kidney, heart, and brain injury.
Results: All enrolled patients were analyzed. The cyclosporine group (136.4 ± 35.6%) showed a more pronounced increase from baseline plasma cystatin C to day 3 compared to placebo (115.9 ± 30.8%), difference, 20.6% (95% CI, 10.2 to 31.2%, P < 0.001). The same pattern was observed for the other renal markers. The cyclosporine group had more patients in Risk Injury Failure Loss End-stage (RIFLE) groups R (risk), I (injury), or F (failure; 31% vs. 8%, P < 0.001). There were no differences in safety parameter distribution between groups.
Conclusions: Administration of cyclosporine did not protect coronary artery bypass grafting patients from acute kidney injury. Instead, cyclosporine caused a decrease in renal function compared to placebo that resolved after 1 month.
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