Li Xin-Ya, Chen Wei-Sheng, Qu Zhong-Kai, Chen Jian-Guang, Li Li, Li Shu-Na, Wang Yu, Lyu Jun
Clinical Research Center, the First Affiliated Hospital of Jinan University, Guangzhou, 510630, China.
Department of Intensive Care Unit, the First Affiliated Hospital of Jinan University, Guangzhou, 510630, China.
Mil Med Res. 2025 Aug 21;12(1):51. doi: 10.1186/s40779-025-00641-z.
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.
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.
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.
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.
大多数脓毒症患者会发生脓毒症相关急性肾损伤（SA-AKI），这对生存构成重大威胁且缺乏特异性治疗方法。迄今为止，尚无已发表的随机对照试验证实脓毒症患者使用白蛋白与SA-AKI发生之间存在关联。因此，尚不清楚使用白蛋白是否会影响SA-AKI的风险。
本研究采用目标试验模拟法，利用观察性数据追踪2008年至2022年期间最初入住马萨诸塞州波士顿贝斯以色列女执事医疗中心重症监护病房达7天的成年脓毒症患者。使用克隆审查权重（CCW）方法控制不朽时间偏倚，并采用新用户设计来解决当前用户偏倚问题。暴露变量为脓毒症发作后早期给予白蛋白。根据白蛋白使用情况，将患者分为两组：白蛋白组（n = 27088）和无白蛋白组（n = 27088）。主要结局为SA-AKI的发生，次要结局为7天全因死亡率。使用竞争风险分析对主要结局进行分析。此外，还进行了敏感性分析和亚组分析。
在分析的27088例患者中，与未使用白蛋白相比，使用白蛋白与显著更高的SA-AKI风险相关（相对差异=3.47%，95%CI 1.76 - 5.23）。7天生存率无临床意义上的差异（相对差异=0.05%，95%CI -2.30至2.45）。敏感性分析一致支持这些结果。所有这些分析均基于CCW后收集的数据进行。
早期给予白蛋白可能会增加脓毒症患者发生SA-AKI的风险，且未带来短期生存获益。这些结果强调在将白蛋白纳入脓毒症复苏方案时需要进行严格的风险效益评估，并突出了进一步临床验证的必要性。然而，鉴于本研究的探索性和初步性质，在解释本研究结论时应谨慎。
