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Early use of albumin may increase the risk of sepsis-associated acute kidney injury in sepsis patients:a target trial emulation
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作者 Xin-Ya Li Wei-Sheng Chen +5 位作者 Zhong-Kai Qu Jian-Guang Chen Li Li Shu-Na Li Yu Wang Jun Lyu 《Military Medical Research》 2026年第2期198-208,共11页
Background:Most sepsis patients develop sepsis-associated acute kidney injury(SA-AKI),which poses a significant threat to survival and lacks specific treatment.To date,there are no published randomized controlled tria... Background:Most sepsis patients develop sepsis-associated acute kidney injury(SA-AKI),which poses a significant threat to survival and lacks specific treatment.To date,there are no published randomized controlled trials that have established a link between albumin use and SA-AKI development in sepsis.Therefore,it is unclear whether albumin use may influence the risk of SA-AKI.Methods:The present study employed a target trial emulation using observational data to track adult sepsis patients initially admitted to the intensive care unit at Beth Israel Deaconess Medical Center,Boston,Massachusetts,for a period of 7 d from 2008 to 2022.Immortal time bias was controlled using the clone-censor-weight(CCW)method,along with a new-user design to address current user bias.The exposure variable was the early administration of albumin following the onset of sepsis.Based on albumin use,patients were classified into two groups:the albumin group(n=27,088)and the no albumin group(n=27,088).The primary outcome was the development of SA-AKI,and the secondary outcome was 7-day all-cause mortality.The primary outcome was analyzed using competing risk analyses.Furthermore,sensitivity and subgroup analyses were also performed.Results:Among the 27,088 patients analyzed,albumin administration was associated with a significantly higher SA-AKI risk(relative difference=3.47%,95%CI 1.76-5.23)compared to non-administration.There was no clinically meaningful difference in 7-day survival(relative difference=0.05%,95%CI-2.30 to 2.45).Sensitivity analyses consistently supported these results.All these analyses were conducted on data that were collected after CCW.Conclusions:Early albumin administration may increase the risk of SA-AKI in sepsis patients without conferring a short-term survival benefit.These results underscore the need for a rigorous risk-benefit assessment when incorporating albumin into sepsis resuscitation protocols and highlight the need for further clinical validation.However,it is important to exercise caution when interpreting the conclusions of this study,given its exploratory and preliminary nature. 展开更多
关键词 Target trial emulation clone-censor-weight(CCW) Sepsis-associated acute kidney injury(SA-AKI) ALBUMIN
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《药物流行病学研究方法学指南(第2版)》系列解读(14):目标试验仿真研究的应用与案例
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作者 赵厚宇 程吟楚 +1 位作者 孙凤 詹思延 《药物流行病学杂志》 2026年第2期121-132,共12页
目标试验仿真(TTE)逐渐发展为药物流行病学研究因果推断的主流框架,通过仿真随机对照试验的设计要素,显著提升观察性研究的质量。本文基于《药物流行病学研究方法学指南(第2版)》,对TTE方法常用设计的基本原理进行解读,重点介绍活性药... 目标试验仿真(TTE)逐渐发展为药物流行病学研究因果推断的主流框架,通过仿真随机对照试验的设计要素,显著提升观察性研究的质量。本文基于《药物流行病学研究方法学指南(第2版)》,对TTE方法常用设计的基本原理进行解读,重点介绍活性药物对照新用药者设计、序贯试验、克隆-删失-加权三种常用的TTE设计的基本原理、适用场景、实施步骤,并分别结合典型研究案例,展示其在药物流行病学中的具体应用,最后对三种设计的基本特征进行比较,并就如何根据研究目的选择合适的设计类型提出了参考意见。 展开更多
关键词 目标试验仿真 药物流行病学 方法学 指南 活性药物对照新用药者设计 序贯试验 克隆-删失-加权
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