Department of Intensive Care, Austin Hospital, Melbourne, VIC, Australia.
Department of Emergency and Critical Care Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Intensive Care Med. 2024 Jul;50(7):1049-1063. doi: 10.1007/s00134-024-07480-x. Epub 2024 May 27.
Acute kidney injury (AKI) is associated with persistent renal dysfunction, the receipt of dialysis, dialysis dependence, and mortality. Accordingly, the concept of major adverse kidney events (MAKE) has been adopted as an endpoint for assessing the impact of AKI. However, applied criteria or observation periods for operationalizing MAKE appear to vary across studies. To evaluate this heterogeneity for MAKE evaluation, we performed a systematic scoping review of studies that employed MAKE as an AKI endpoint. Four major academic databases were searched, and we identified 122 studies with increasing numbers over time. We found marked heterogeneity in applied criteria and observation periods for MAKE across these studies, with some even lacking a description of criteria. Moreover, 13 different observation periods were employed, with 30 days and 90 days as the most common. Persistent renal dysfunction was evaluated by estimated glomerular filtration rate (34%) or serum creatinine concentration (48%); however, 37 different definitions for this component were employed in terms of parameters, cut-off criteria, and assessment periods. The definition for the dialysis component also showed significant heterogeneity regarding assessment periods and duration of dialysis requirement (chronic vs temporary). Finally, MAKE rates could vary by 7% [interquartile range: 1.7-16.7%] with different observation periods or by 36.4% with different dialysis component definitions. Our findings revealed marked heterogeneity in MAKE definitions, particularly regarding component assessment and observation periods. Dedicated discussion is needed to establish uniform and acceptable standards to operationalize MAKE in terms of selection and applied criteria of components, observation period, and reporting criteria for future trials on AKI and related conditions.
急性肾损伤 (AKI) 与持续性肾功能障碍、透析治疗、透析依赖和死亡率有关。因此,已经采用主要不良肾脏事件 (MAKE) 的概念作为评估 AKI 影响的终点。然而,用于实施 MAKE 的应用标准或观察期似乎因研究而异。为了评估 MAKE 评估的这种异质性,我们对将 MAKE 用作 AKI 终点的研究进行了系统的范围审查。我们搜索了四个主要的学术数据库,并确定了随时间推移数量不断增加的 122 项研究。我们发现这些研究中 MAKE 的应用标准和观察期存在明显的异质性,有些甚至缺乏标准的描述。此外,使用了 13 个不同的观察期,30 天和 90 天最常见。通过估算肾小球滤过率 (34%) 或血清肌酐浓度 (48%) 评估持续性肾功能障碍;然而,该组成部分采用了 37 种不同的定义,涉及参数、截止标准和评估期。透析组件的定义在评估期和透析需求持续时间(慢性与临时)方面也存在显著的异质性。最终,使用不同的观察期或不同的透析组件定义,MAKE 发生率可能相差 7%[四分位距:1.7-16.7%];使用不同的观察期或不同的透析组件定义,MAKE 发生率可能相差 36.4%。我们的研究结果表明,MAKE 定义存在明显的异质性,特别是在组件评估和观察期方面。需要进行专门的讨论,以根据组件的选择和应用标准、观察期以及 AKI 和相关病症的未来试验的报告标准,为 MAKE 的实施建立统一和可接受的标准。
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