【原】【罂粟摘要】通过在生物标志物鉴定的高危患者中实施KDIGO指南来预防心脏手术相关的急性肾损伤：PrevAKI-多中心随机对照试验

通过在生物标志物鉴定的高危患者中实施KDIGO指南来预防心脏手术相关的急性肾损伤：预防急性肾损伤的一项多中心随机对照试验

贵州医科大学 麻醉与心脏电生理课题组

翻译：潘志军    编辑：潘志军    审校：曹莹

背景

前瞻性单中心试验表明，在高危患者中实施改善全球肾脏病预后组织（KDIGO）指南显著降低了手术后急性肾损伤（AKI）的发生。我们试图评估在多中心环境下对进行心脏手术的高危患者实施基于KDIGO指南的一系列支持措施的可行性，以为大型确定性试验做准备。

方法

在这个多中心、跨国、随机对照试验中，我们调查了KDIGO捆绑疗法的依从性，包括容量状态和血流动力学的优化，功能性血流动力学监测，避免肾毒性药物，并对心脏手术后通过尿液生物标志物金属蛋白酶2组织抑制剂（TIMP-2）和胰岛素样生长因子结合蛋白质类-7（IGFBP7）鉴定的高危患者进行高血糖的预防。主要观察结果是捆绑疗法的依从性，并对符合条件的患者根据Clopper-Pearson95%置信区间（CI）进行其比例的评估。次要观察结果包括AKI的发生和严重程度。

结果

最终分析总共纳入了278名患者。在干预组中，65.4%的患者接受完整的捆绑治疗，而对照组为4.2%（绝对风险降低[ARR] 61.2% [95%CI，52.6～69.9]；P<0.001）。两组AKI发生率差异无统计学意义（干预组为46.3%，对照组为41.5%;ARR−4.8%[95%CI，−16.4～6.9]；P=0.423）。然而，与对照组相比，干预组中、重度AKI的发生率显著降低（14.0%比23.9%；ARR 10.0%[95%CI，0.9～19.1]；P=0.034）。对其他指定的次要观察结果没有显著影响。

结论

在多个国家中实施基于KDIGO指南的捆绑治疗是可行的。此外，干预组中度至重度AKI显著降低。

原始文献来源：

Alexander Zarbock, Mira Küllmar ,Marlies Ostermann, et al. Prevention of Cardiac Surgery–Associated Acute Kidney Injury by Implementing the KDIGO Guidelines in High-Risk Patients Identified by Biomarkers: The PrevAKI-Multicenter Randomized Controlled Trial[J]. (Anesth Analg 2021 Aug 01;133(2)).

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英文原文👇

Prevention of Cardiac Surgery–Associated Acute Kidney Injury by Implementing the KDIGO Guidelines in High-Risk Patients Identified by Biomarkers: The PrevAKI-Multicenter Randomized Controlled Trial

Abstract

Background: Prospective, single-center trials have shown that the implementation of the Kidney Disease: Improving Global Outcomes (KDIGO) recommendations in high-risk patients significantly reduced the development of acute kidney injury (AKI) after surgery. We sought to evaluate the feasibility of implementing a bundle of supportive measures based on the KDIGO guideline in high-risk patients undergoing cardiac surgery in a multicenter setting in preparation for a large definitive trial.

Methods: In this multicenter , multinational, randomized controlled trial, we examined the adherence to the KDIGO bundle consisting of optimization of volume status and hemodynamics, functional hemodynamic monitoring, avoidance of nephrotoxic drugs, and prevention of hyperglycemia in high-risk patients identified by the urinary biomarkers tissue inhibitor of metalloproteinases-2 [TIMP-2] and insulin growth factor-binding protein 7 [IGFBP7] after cardiac surgery. The primary end point was the adherence to the bundle protocol and was evaluated by the percentage of compliant patients with a 95% confidence interval (CI) according to Clopper-Pearson. Secondary end points included the development and severity of AKI.

Results: In total, 278 patients were included in the final analysis. In the intervention group, 65.4% of patients received the complete bundle as compared to 4.2% in the control group (absolute risk reduction [ARR] 61.2 [95% CI, 52.6-69.9]; P <0.001). AKI rates were statistically not different in both groups (46.3% intervention versus 41.5% control group; ARR −4.8% [95% CI, −16.4 to 6.9]; P =0.423). However , the occurrence of moderate and severe AKI was significantly lower in the intervention group as compared to the control group (14.0% vs 23.9%; ARR 10.0% [95% CI, 0.9-19.1]; P =0.034). There were no significant effects on other specified secondary outcomes.

Conclusions: Implementation of a KDIGO-derived treatment bundle is feasible in a multinational setting. Furthermore, moderate to severe AKI was significantly reduced in the intervention group.