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白蛋白在降低心脏手术相关急性肾损伤中的潜在作用:一项随机对照试验。

The Potential Role of Albumin in Reducing Cardiac Surgery-Associated Acute Kidney Injury: A Randomized Controlled Trial.

作者信息

Miralles Bagán Jordi, Parrilla Quiles Laura, Paniagua Iglesias Pilar, Betbesé Roig Antoni J, Sabaté Tenas Sergi, Pérez García Sergio, García Álvarez Mercedes

机构信息

Department of Anesthesiology, Reanimation and Pain Therapy, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.

Department of Anesthesiology, Reanimation and Pain Therapy, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.

出版信息

J Cardiothorac Vasc Anesth. 2025 Feb;39(2):453-460. doi: 10.1053/j.jvca.2024.10.012. Epub 2024 Oct 16.

DOI:10.1053/j.jvca.2024.10.012
PMID:39922683
Abstract

OBJECTIVES

Cardiac surgery-associated acute kidney injury (CSA-AKI) is a common complication with high morbidity and mortality. This study was designed to determine whether adding human albumin to the cardiopulmonary bypass (CPB) priming solution reduces the incidence of CSA-AKI.

DESIGN

A double-blind, randomized controlled trial (RCT) involving 248 patients scheduled for cardiac surgery with CPB.

SETTING

A single-center tertiary university hospital.

PARTICIPANTS

Adults with a baseline estimated glomerular filtration rate (eGFR) of ≥60 mL/min/1.73 m and left ventricular ejection fraction ≥40%.

INTERVENTIONS

Patients were randomized to receive either a crystalloid priming solution (Plasma-Lyte) plus 4% albumin (intervention group, n = 126) or a crystalloid solution alone (control group, n = 122) for CPB.

MEASUREMENTS AND MAIN RESULTS

Data analyses were performed using the Chi-square test and Student's t-test, or their nonparametric equivalent. The primary outcome was the incidence of CSA-AKI, as defined by the Kidney Disease Improving Global Outcomes criteria, within 5 days postoperatively. Both cohorts were comparable in baseline and perioperative characteristics, including preoperative albumin levels. The incidence of CSA-AKI was 29.3% (n = 37) in the intervention group compared with 31.2% (n = 38) in the control group (odds ratio: 0.91, 95% confidence interval: 0.53-1.58). The observed difference in CSA-AKI incidence between the groups was not statistically significant. A post-hoc subgroup analysis of patients with a baseline eGFR of 60 to 70 mL/min/1.73 m² indicated a trend toward a reduced incidence of CSA-AKI in the intervention group compared with the control group (35.7% v 57.6%; odds ratio: 0.41, 95% confidence interval: 0.16-1.03). This trend was not observed in patients with an eGFR greater than 70 mL/min/1.73 m². No significant differences were observed between groups for the need for inotropes or vasoconstrictors, incidence of cardiogenic or distributive shock, bleeding, need for transfusion, or use of nephrotoxic drugs.

CONCLUSIONS

Adding albumin to the CPB priming solution did not decrease the incidence of CSA-AKI in patients with normal preoperative renal function. These findings suggest that albumin might benefit patients with impaired renal function, warranting further investigation.

摘要

目的

心脏手术相关急性肾损伤(CSA-AKI)是一种常见并发症,发病率和死亡率都很高。本研究旨在确定在体外循环(CPB)预充液中添加人白蛋白是否能降低CSA-AKI的发生率。

设计

一项双盲、随机对照试验(RCT),纳入248例计划接受CPB心脏手术的患者。

地点

一所单中心三级大学医院。

参与者

基线估计肾小球滤过率(eGFR)≥60 mL/min/1.73 m²且左心室射血分数≥40%的成年人。

干预措施

患者被随机分为两组,CPB时分别接受晶体预充液(Plasma-Lyte)加4%白蛋白(干预组,n = 126)或单纯晶体溶液(对照组,n = 122)。

测量指标及主要结果

采用卡方检验和学生t检验或其非参数等价方法进行数据分析。主要结局指标是术后5天内根据改善全球肾脏病预后组织(KDIGO)标准定义的CSA-AKI发生率。两组在基线和围手术期特征方面具有可比性,包括术前白蛋白水平。干预组CSA-AKI发生率为29.3%(n = 37),对照组为31.2%(n = 38)(优势比:0.91,95%置信区间:0.53 - 1.58)。两组间观察到的CSA-AKI发生率差异无统计学意义。对基线eGFR为60至70 mL/min/1.73 m²的患者进行的事后亚组分析表明,与对照组相比,干预组CSA-AKI发生率有降低趋势(35.7%对57.6%;优势比:0.41,95%置信区间:0.16 - 1.03)。在eGFR大于70 mL/min/1.73 m²的患者中未观察到这种趋势。两组在使用血管活性药物的需求、心源性或分布性休克的发生率、出血、输血需求或肾毒性药物使用方面未观察到显著差异。

结论

在CPB预充液中添加白蛋白并未降低术前肾功能正常患者的CSA-AKI发生率。这些发现表明白蛋白可能对肾功能受损患者有益,值得进一步研究。

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