Biomarker-guided implementation of the KDIGO guidelines to reduce the occurrence of acute kidney injury in patients after cardiac surgery (PrevAKI-multicentre): protocol for a multicentre, observational study followed by randomised controlled feasibility trial
Biomarker-guided implementation of the KDIGO guidelines to reduce the occurrence of acute kidney injury in patients after cardiac surgery (PrevAKI-multicentre): protocol for a multicentre, observational study followed by randomised controlled feasibility trial
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DOI：
10.1136/bmjopen-2019-034201
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发表时间：
2020-04-01
期刊：
影响因子：
2.9
通讯作者：
Zarbock, Alexander
中科院分区：
文献类型：
--
作者：
Kuellmar, Mira;Massoth, Christina;Zarbock, Alexander
引言急性肾损伤（阿基）是心脏手术后常见的并发症，具有不良的短期和长期结果。尽管强烈建议预防阿基（PrevAKI），但最佳策略尚不确定。肾脏疾病：改善全球结局（KDIGO）指南建议在高危患者中采取一系列支持性措施。在一项单中心试验中，我们最近证明了KDIGO束的严格实施显著降低了心脏手术后阿基的发生率。在这项可行性研究中，我们的目的是评估是否可以实施的研究方案在一个多中心的设置，准备一个大型的multicentre trial.Methods和analysis我们计划进行一项前瞻性的，观察性的调查，然后随机对照，多中心，多国临床试验，包括280例接受心脏手术与心肺转流。观察性调查的目的是探索在常规临床实践中对KDIGO建议的依从性。第二阶段是随机对照试验。目的是研究试验方案是否可在大型多中心、多国环境中实施。介入部分的主要终点为方案依从率。次要终点包括术后72小时内发生的任何阿基和中度/重度阿基（根据KDIGO标准定义）、第90天的肾脏恢复、第30、60和90天的肾脏替代治疗（RRT）和死亡率、由持续性肾功能不全、第90天的RRT和死亡率组成的联合终点主要不良肾脏事件以及安全性结局。
Introduction Acute kidney injury (AKI) is a frequent complication after cardiac surgery with adverse short-term and long-term outcomes. Although prevention of AKI (PrevAKI) is strongly recommended, the optimal strategy is uncertain. The Kidney Disease: Improving Global Outcomes (KDIGO) guideline recommended a bundle of supportive measures in high-risk patients. In a single-centre trial, we recently demonstrated that the strict implementation of the KDIGO bundle significantly reduced the occurrence of AKI after cardiac surgery. In this feasibility study, we aim to evaluate whether the study protocol can be implemented in a multicentre setting in preparation for a large multicentre trial.Methods and analysis We plan to conduct a prospective, observational survey followed by a randomised controlled, multicentre, multinational clinical trial including 280 patients undergoing cardiac surgery with cardiopulmonary bypass. The purpose of the observational survey is to explore the adherence to the KDIGO recommendations in routine clinical practice. The second phase is a randomised controlled trial. The objective is to investigate whether the trial protocol is implementable in a large multicentre, multinational setting. The primary endpoint of the interventional part is the compliance rate with the protocol. Secondary endpoints include the occurrence of any AKI and moderate/severe AKI as defined by the KDIGO criteria within 72 hours after surgery, renal recovery at day 90, use of renal replacement therapy (RRT) and mortality at days 30, 60 and 90, the combined endpoint major adverse kidney events consisting of persistent renal dysfunction, RRT and mortality at day 90 and safety outcomes.