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AKI-A Relevant Safety End Point?
American Journal of Kidney Diseases ( IF 13.2 ) Pub Date : 2020-02-06 , DOI: 10.1053/j.ajkd.2019.11.010
Ian E McCoy 1 , Glenn M Chertow 1
Affiliation  

Acute kidney injury (AKI) is a common outcome evaluated in clinical studies, often as a safety end point in a variety of cardiovascular, kidney disease, and other clinical trials. AKI end points that include modest increases in serum creatinine levels from baseline may not associate with patient-centered outcomes such as initiation of dialysis, sustained decline in kidney function, or death. Surprisingly, data from several randomized controlled trials have suggested that in certain settings, the development of AKI may be associated with favorable outcomes. AKI safety end points that are nonspecific and may not associate with patient-centered outcomes could result in beneficial therapies being inappropriately withheld or never developed for commercial use. We review several issues related to commonly used AKI definitions and suggest that future work in AKI use more patient-centered AKI end points such as major adverse kidney events at 30 days or other later time points.

中文翻译:

AKI-A相关的安全终点?

急性肾损伤(AKI)是临床研究中评估的常见结局,通常是各种心血管,肾脏疾病和其他临床试验中的安全终点。AKI终点包括血清肌酐水平相对于基线的适度增加,可能与以患者为中心的结果(例如开始透析,肾脏功能持续下降或死亡)无关。令人惊讶的是,一些随机对照试验的数据表明,在某些情况下,AKI的发展可能与良好的预后相关。非特异性的AKI安全终点可能不会与以患者为中心的结果相关联,可能会导致不适当地放弃有益疗法或从未开发出可用于商业用途的有益疗法。
更新日期:2020-02-07
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