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通过对生物标志物识别的高危患者实施 KDIGO 指南预防心脏手术相关急性肾损伤：PrevAKI 多中心随机对照试验。

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.

机构信息

From the Department of Anesthesiology, Intensive Care Medicine and Pain Medicine, University Hospital Münster, Münster, Germany.

Department of Critical Care, Guy's & St Thomas' National Health Service Foundation Hospital, London, United Kingdom.

出版信息

Anesth Analg. 2021 Aug 1;133(2):292-302. doi: 10.1213/ANE.0000000000005458.

DOI:10.1213/ANE.0000000000005458

PMID:33684086

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 < .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 = .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 = .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.

摘要

背景

前瞻性、单中心试验表明，在高危患者中实施肾脏病：改善全球结局（KDIGO）建议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中为一项大型确定性试验做准备，在心脏手术高危患者中实施基于 KDIGO 指南的支持措施包的可行性。

方法

在这项多中心、多国、随机对照试验中，我们检查了接受心脏手术后尿液生物标志物组织金属蛋白酶抑制剂-2（TIMP-2）和胰岛素样生长因子结合蛋白 7（IGFBP7）鉴定的高危患者对 KDIGO 包的依从性，该包包括优化容量状态和血液动力学、功能血液动力学监测、避免肾毒性药物和预防高血糖。主要终点是根据 Clopper-Pearson 评估的符合方案患者的依从性百分比及其 95%置信区间（CI）。次要终点包括 AKI 的发生和严重程度。

结果

共有 278 例患者纳入最终分析。在干预组中，65.4%的患者接受了完整的方案，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 发生率无统计学差异（干预组 46.3%，对照组 41.5%；ARR-4.8%[95%CI，-16.4 至 6.9]；P=0.423）。然而，与对照组相比，干预组中中度和重度 AKI 的发生率显著降低（14.0%对 23.9%；ARR 10.0%[95%CI，0.9-19.1]；P=0.034）。其他指定的次要结局无显著影响。