Facultat de Medicina Campus de Bellvitge Universitat de Barcelona L'Hospitalet de Llobregat, Barcelona, Spain.
Institut de Investigació Biomédica de Bellvitge L'Hospitalet de Llobregat, Barcelona, Spain.
JAMA. 2024 Nov 5;332(17):1446-1454. doi: 10.1001/jama.2024.20630.
Cardiac surgery-associated acute kidney injury (CSA-AKI) remains a significant problem following cardiopulmonary bypass (CPB). Various strategies are proposed to attenuate CSA-AKI, including extracorporeal blood purification (EBP), but little is known about the effect of EBP through an acrylonitrile-sodium methallylsulfonate/polyethyleneimine membrane during CPB.
To determine whether the use of an EBP device in a nonemergent cardiac surgery population reduces CSA-AKI after CPB.
DESIGN, SETTING, AND PARTICIPANTS: This double-blind, randomized clinical trial was conducted in 2 tertiary hospitals in Spain. Patients 18 years or older undergoing nonemergent cardiac surgery who were at high risk for CSA-AKI were enrolled from June 15, 2016, through November 5, 2021, with follow-up data through February 5, 2022. Of 1156 patients assessed, 343 patients were randomized (1:1) to either receive EBP or standard care.
Nonselective EBP device connected to the CPB circuit.
The primary outcome was the rate of CSA-AKI in the 7 days after randomization.
Among 343 patients randomized (169 to receive EBP and 174 to receive usual care), the mean (SD) age was 69 (9) years and 119 were females. The rate of CSA-AKI was 28.4% (95% CI, 21.7%-35.8%) in the EBP group vs 39.7% (95% CI, 32.3%-47.3%) in the standard care group (P = .03), with an adjusted difference of 10.4% (95% CI, 2.3%-18.5%) using a log-binomial model (P = .01). No significant differences (P > .05) were observed in most of the predefined clinical secondary end points or post hoc exploratory end points. In a sensitivity analysis, EBP was found to be more effective in terms of CSA-AKI reduction in patients with chronic kidney disease, diabetes, hypertension, low left ventricular ejection fraction (<40%), and lower body mass index (<30). No differences were observed between the groups in adverse events tracking.
The use of a nonselective EBP device connected to the CPB circuit in a nonemergent population of patients undergoing cardiac surgery was associated with a significant reduction of CSA-AKI in the first 7 days after surgery.
ClinicalTrials.gov Identifier: NCT02518087.
体外循环（CPB）后，与心脏手术相关的急性肾损伤（CSA-AKI）仍然是一个重大问题。各种策略被提出以减轻 CSA-AKI，包括体外血液净化（EBP），但对于 CPB 期间使用丙烯腈-亚甲基磺酸钠/聚乙烯亚胺膜的 EBP 装置的效果知之甚少。
确定在非紧急心脏手术人群中使用 EBP 设备是否会降低 CPB 后的 CSA-AKI。
设计、地点和参与者：这是一项在西班牙 2 家三级医院进行的双盲、随机临床试验。2016 年 6 月 15 日至 2021 年 11 月 5 日，招募了年龄在 18 岁或以上、有 CSA-AKI 高风险的非紧急心脏手术患者，随访数据至 2022 年 2 月 5 日。在评估的 1156 名患者中，有 343 名患者被随机（1:1）分为接受 EBP 或标准护理。
非选择性 EBP 装置连接到 CPB 回路。
主要结局是随机分组后 7 天内 CSA-AKI 的发生率。
在 343 名随机分组的患者（EBP 组 169 例，标准护理组 174 例）中，平均（SD）年龄为 69（9）岁，119 例为女性。EBP 组 CSA-AKI 发生率为 28.4%（95%CI，21.7%-35.8%），标准护理组为 39.7%（95%CI，32.3%-47.3%）（P=0.03），使用对数二项式模型调整后的差异为 10.4%（95%CI，2.3%-18.5%）（P=0.01）。大多数预先设定的临床次要终点或事后探索性终点均未观察到显著差异（P>0.05）。在敏感性分析中，EBP 在患有慢性肾脏病、糖尿病、高血压、左心室射血分数较低（<40%）和较低体重指数（<30%）的患者中降低 CSA-AKI 的效果更为显著。两组在不良事件跟踪方面没有差异。
在非紧急心脏手术患者中，使用 CPB 回路连接的非选择性 EBP 装置可显著降低术后 7 天内 CSA-AKI 的发生率。
ClinicalTrials.gov 标识符：NCT02518087。
