Department of Anesthesiology, Wexner Medical Center at the Ohio State University Columbus, OH, USA.
Metrolina Nephrology Associates Charlotte, NC, USA.
Front Pharmacol. 2014 Jun 2;5:127. doi: 10.3389/fphar.2014.00127. eCollection 2014.
Cardiac surgery associated acute kidney injury (CSA-AKI) is associated with poor outcomes including increased mortality, length of hospital stay (LOS) and cost. The incidence of acute kidney injury (AKI) is reported to be between 3 and 30% depending on the definition of AKI. We designed a multicenter randomized controlled trial to test our hypothesis that a perioperative infusion of sodium bicarbonate (SB) during cardiac surgery will attenuate the post-operative rise in creatinine indicating renal injury when compared to a perioperative infusion with normal saline. An interim analysis was performed after data was available on the first 120 participants. A similar number of patients in the two treatment groups developed AKI, defined as an increase in serum creatinine the first 48 h after surgery of 0.3 mg/dl or more. Specifically 14 patients (24%) who received sodium chloride (SC) and 17 patients (27%) who received SB were observed to develop AKI post-surgery, resulting in a relative risk of AKI of 1.1 (95% CI: 0.6-2.1, chi-square p-value = 0.68) for patients receiving SB compared to those who received SC. The data safety monitoring board for the trial recommended closing the study early as there was only a 12% probability that the null hypothesis would be rejected. We therefore concluded that a perioperative infusion of SB failed to attenuate the risk of CSA-AKI.
心脏手术相关急性肾损伤 (CSA-AKI) 与不良预后相关,包括死亡率增加、住院时间 (LOS) 延长和费用增加。急性肾损伤 (AKI) 的发生率据报道在 3%至 30%之间,具体取决于 AKI 的定义。我们设计了一项多中心随机对照试验,以检验我们的假设,即在心脏手术期间输注碳酸氢钠 (SB) 可减轻术后肌酐升高,表明与围手术期输注生理盐水相比肾脏损伤。在第一批 120 名参与者的数据可用后进行了中期分析。在两个治疗组中,均有相似数量的患者发生 AKI,定义为术后 48 小时内血清肌酐升高 0.3mg/dl 或以上。具体来说,接受氯化钠 (SC) 的 14 名患者(24%)和接受 SB 的 17 名患者(27%)术后观察到发生 AKI,因此与接受 SC 的患者相比,接受 SB 的患者 AKI 的相对风险为 1.1(95%CI:0.6-2.1,卡方 p 值=0.68)。试验的数据安全监测委员会建议提前关闭研究,因为否定零假设的概率只有 12%。因此,我们得出结论,围手术期输注 SB 未能降低 CSA-AKI 的风险。