近日，西班牙巴塞罗那大学Xosé L. Pérez-Fernández团队研究了体外血液净化对改善心脏手术相关性急性肾损伤的疗效。2024年10月9日出版的《美国医学会杂志》发表了这项最新研究成果。

心脏手术相关性急性肾损伤（CSA-AKI）仍然是体外循环（CPB）后的一个严重问题。人们提出了各种策略来减弱CSA-AKI，包括体外血液净化（EBP），但人们对CPB期间EBP通过丙烯腈-甲基丙烯磺酸钠/聚乙烯亚胺膜的作用知之甚少。

为了确定在非急诊心脏手术人群中使用EBP装置是否会减少体外循环后的CSA-AKI，研究人员在西班牙的两家三级医院进行了一项双盲随机临床试验。2016年6月15日至2021年11月5日，18岁或以上接受非紧急心脏手术的CSA-AKI高危患者被纳入研究，随访数据至2022年2月5日。在评估的1156名患者中，343名患者被随机（1:1）接受EBP或标准护理。干预措施为连接到CPB的非选择性EBP设备。主要结局是随机化后7天内CSA-AKI的发生率。

在343名随机分配的患者中（169名接受EBP治疗，174名接受常规护理），平均（SD）年龄为69（9）岁，119名为女性。在EBP组中，CSA-AKI的发生率为28.4%（95%置信区间，21.7%-35.8%），而在标准护理组中为39.7%（95%置信区间，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%置信区间，2.3%-18.5%）（P=0.01）。在大多数预定义的临床次要终点或事后探索终点中没有观察到显著差异（P>0.05）。在敏感性分析中，发现EBP在慢性肾病、糖尿病、高血压、左心室射血分数低（<40%）和体重指数低（<30）的患者中，在降低CSA-AKI方面更有效。在不良事件跟踪方面，两组之间没有观察到差异。

研究结果表明，在接受心脏手术的非急诊患者群体中，使用连接到CPB的非选择性EBP装置与术后前7天CSA-AKI的显著降低有关。

附：英文原文

Title: Extracorporeal Blood Purification and Acute Kidney Injury in Cardiac Surgery: The SIRAKI02 Randomized Clinical Trial

Author: Xosé Pérez-Fernández, Arnau Ulsamer, María Cámara-Rosell, Fabrizio Sbraga, Enric Boza-Hernández, Enrique Moret-Ruíz, Erika Plata-Menchaca, Doménech Santiago-Bautista, Patricia Boronat-García, Víctor Gumucio-Sanguino, Judith Peafiel-Muoz, Mercedes Camacho-Pérez, Antoni Betbesé-Roig, Lui Forni, Ana Campos-Gómez, Joan Sabater-Riera, SIRAKI Study Group, Josep Ballus Noguera, Marta Huguet Briba, Rafael Máez Mendiluce, Francesc Esteve Urbano, Eva Santafosta Gómez, Beymar Henry Alanez Saavedra, Virginia Alonso Juste, Laura Anguela Calvet, Renzo Steve ávila Espinoza, Paola Cárdenas Campos, Maria Luisa Carrió Cardona, Teodor Casanovas Lorenzo, Luisa Corral Ansa, Vicente Francisco Corral, Elisabet Farrero Bayarri,, Mari Paz Fuset Cabanes, Rosa Granada Vicente, Juan Carlos López Delgado, Neus López Sue, Krystel Maisterra Santos, Gabriel Jesús Moreno, Eva Oliver Juan, Maria Pons Serra, Elisabet Periche Pedra, Paola Sastre Pérez, Ricard Soley Corderas, David Rodríguez Castro,, Herminia Rosalía Torrado Santos, Maria-Dolores Belda Ley, Fabio Alessandro Di Paolo, Africa Carmen Lores, Stephani-Maria Luna Solis, Ana Rosa Ochagavía Calvo, Pablo Serra Paya, Alejandro Garcia Zaloa, Gemma Via Clavero, Enric Boza Hernández., Albert Gil Dorado, Antonia Bonet Burguera, Esther Mendez Arias, Sara Garcia Ballester, Ariadna Leon Moreno, Raul Senen Herrera, Maite Sanz Iturbe, Jacobo Toscano Fernández, Fabrizio Sbraga, Marcos Potocnik Potocnik, Karina Osorio Higa, Albert Miralles Cassina, Daniel Ortiz Berbel, David Toral Sepúlveda, Arnau Blasco Lucas, Ana Dantas, Belen Cevallos, Javier Tejero, Luis Martinez Sepena, Francis Iglesias Gordillo

Issue&Volume: 2024-10-09

Abstract:

Importance  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.

Objective  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.

Intervention  Nonselective EBP device connected to the CPB circuit.

Main Outcomes and Measures  The primary outcome was the rate of CSA-AKI in the 7 days after randomization.

Results  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.

Conclusions and Relevance  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.

DOI: 10.1001/jama.2024.20630

Source: https://jamanetwork.com/journals/jama/fullarticle/2824929