Shehabi Yahya, Balachandran Mayurathan, Al-Bassam Wisam, Bailey Michael, Bellomo Rinaldo, Bihari Shailesh, Brown Alana, Brown Alastair, Collins David, Darlison Phoebe R, Li Mozhu Alice, Mandarano Raffaele, Sarode Vineet, Pakavakis Adrian
Monash Health School of Clinical Sciences, Clayton, Victoria, Australia.
The Victorian Heart Hospital, Clayton, Victoria, Australia.
JAMA Surg. 2025 Jun 11. doi: 10.1001/jamasurg.2025.1683.
Acute kidney injury (AKI) after cardiac surgery is a common and serious complication. Protein loading appears nephroprotective; thus, continuous hyperoncotic albumin infusion may impact AKI following high-risk cardiac surgery.
To evaluate the effect of postoperative 20% albumin infusion compared with usual care on the occurrence of AKI in high-risk cardiac surgery patients.
DESIGN, SETTING, AND PARTICIPANTS: This was an investigator-initiated randomized multicenter open-label pragmatic clinical trial. Participants were stratified by site and estimated glomerular filtration rate (eGFR) above and below 60 mL/min/1.73 m2. The study was conducted at 7 cardiac centers in Australia and Italy between July 2019 and August 2024. Patients undergoing on-pump cardiac surgery with a preoperative eGFR of greater than 15 mL/min/1.73 m2 and less than 60 mL/min/1.73 m2 or undergoing a combined cardiac surgical procedure or major aortic surgery were included, excluding those who were in intensive care for longer than 6 hours following the index surgery, had a serum albumin level less than 20 g/L, were dialysis dependent, had a previous kidney transplant, were receiving extracorporeal life support or ventricular assist device, or had an objection to receiving albumin or blood products.
Participants were randomized 1:1 within 6 hours after surgery to receive a 300-mL infusion of 20% albumin over 15 hours or usual care, as per clinician discretion. All patients received volume resuscitation and hemodynamic treatment according to participating centers' protocols.
The primary outcome was stage 1-3 AKI according to the creatinine-based Kidney Disease Improving Global Outcomes definition. The main secondary outcomes included major adverse kidney events and mortality at hospital discharge or day 28 following randomization.
The primary analysis included 307 patients randomized to the 20% albumin group and 304 to usual care. The mean (SD) age was 69 (10.8) years, and 281 patients (45.8%) had an eGFR less than 60 mL/min/1.73 m2. The median (IQR) European System for Cardiac Operative Risk Evaluation score-II was 3.23 (1.91-5.30). AKI occurred in 150 of 307 patients in the albumin group (48.9%) vs 132 of 304 in usual care (43.4%) (unadjusted relative risk, 1.13; 95% CI, 0.95-1.34; P = .18; strata-adjusted relative risk, 1.12; 95% CI, 1.04-1.21; P = .003). This effect was more pronounced in patients with an eGFR of <60 mL/min/1.73 m2 (adjusted relative risk, 1.14; 95% CI; 1.07-1.22; P < .001). There were more blood transfusions given in the albumin group (116 [37.8%] vs 91 [29.9%]; P = .04) but no other significant differences in secondary outcomes.
In this study of cardiac surgery patients at high risk of AKI, an infusion of 20% albumin increased the risk of AKI. These findings do not support the routine use of hyperoncotic albumin infusion in patients undergoing high-risk cardiac surgery.
Anzctr.org.au Identifier: ACTRN12619001355167.
心脏手术后急性肾损伤（AKI）是一种常见且严重的并发症。蛋白质负荷似乎具有肾保护作用；因此，持续输注高渗白蛋白可能会影响高危心脏手术后的急性肾损伤。
评估术后输注20%白蛋白与常规治疗相比，对高危心脏手术患者急性肾损伤发生情况的影响。
设计、设置和参与者：这是一项由研究者发起的随机多中心开放标签实用临床试验。参与者按地点以及估计肾小球滤过率（eGFR）高于和低于60 mL/min/1.73 m²进行分层。该研究于2019年7月至2024年8月在澳大利亚和意大利的7个心脏中心进行。纳入术前eGFR大于15 mL/min/1.73 m²且小于60 mL/min/1.73 m²、接受体外循环心脏手术或联合心脏手术或主动脉大手术的患者，排除那些在索引手术后在重症监护室停留超过6小时、血清白蛋白水平低于20 g/L、依赖透析、有过肾移植史、接受体外生命支持或心室辅助装置，或拒绝接受白蛋白或血液制品的患者。
参与者在术后6小时内按1:1随机分组，根据临床医生的判断，在15小时内接受300 mL的20%白蛋白输注或常规治疗。所有患者均根据参与中心的方案接受容量复苏和血流动力学治疗。
主要结局是根据基于肌酐的改善全球肾脏病预后定义的1 - 3期急性肾损伤。主要次要结局包括重大不良肾脏事件以及随机分组后出院时或第28天的死亡率。
初步分析纳入了307例随机分配至20%白蛋白组的患者和304例接受常规治疗的患者。平均（标准差）年龄为69（10.8）岁，281例患者（45.8%）的eGFR低于60 mL/min/1.73 m²。欧洲心脏手术风险评估系统评分 - II的中位数（四分位间距）为3.23（1.91 - 5.30）。白蛋白组307例患者中有150例（48.9%）发生急性肾损伤，常规治疗组304例中有132例（43.4%）发生急性肾损伤（未调整相对风险，1.13；95%置信区间，0.95 - 1.34；P = .18；分层调整相对风险，1.12；95%置信区间，1.04 - 1.21；P = .003）。这种影响在eGFR <60 mL/min/1.73 m²的患者中更为明显（调整后相对风险，1.14；95%置信区间；1.07 - 1.22；P < .001）。白蛋白组输血次数更多（116例[37.8%]对91例[29.9%]；P = .04），但次要结局方面无其他显著差异。
在这项针对急性肾损伤高危心脏手术患者的研究中，输注20%白蛋白增加了急性肾损伤的风险。这些发现不支持在高危心脏手术患者中常规使用高渗白蛋白输注。
Anzctr.org.au标识符：ACTRN12619001355167。
