体外血液净化与心脏手术中的急性肾损伤:SIRAKI02 随机临床试验。

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 Peñafiel-Muñoz, Mercedes Camacho-Pérez, Antoni Betbesé-Roig, Lui Forni, Ana Campos-Gómez, Joan Sabater-Riera
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引用次数: 0

摘要

重要性:心脏手术相关急性肾损伤(CSA-AKI)仍然是心肺旁路(CPB)术后的一个重要问题。人们提出了包括体外血液净化(EBP)在内的各种减轻 CSA-AKI 的策略,但对 CPB 期间通过丙烯腈-甲基烯丙基磺酸钠/聚乙烯亚胺膜进行 EBP 的效果却知之甚少:目的:确定在非急诊心脏手术人群中使用 EBP 装置是否可减少 CPB 后的 CSA-AKI:这项双盲随机临床试验在西班牙的两家三级医院进行。从 2016 年 6 月 15 日到 2021 年 11 月 5 日,接受非紧急心脏手术的 18 岁或以上 CSA-AKI 高风险患者被纳入试验,随访数据截止到 2022 年 2 月 5 日。在接受评估的 1156 名患者中,343 名患者被随机分配(1:1)接受 EBP 或标准护理:主要结果和测量指标:主要结果和测量:主要结果是随机化后 7 天内 CSA-AKI 的发生率:在343名随机患者中(169名接受EBP治疗,174名接受常规治疗),平均(标清)年龄为69(9)岁,119名为女性。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 = .03),使用对数二叉模型调整后的差异为 10.4%(95% CI,2.3%-18.5%)(P = .01)。在大多数预定义的临床次要终点或事后探索性终点中均未观察到明显差异(P > .05)。在一项敏感性分析中发现,EBP 在降低慢性肾病、糖尿病、高血压、左室射血分数低的患者 CSA-AKI 方面更为有效:在接受心脏手术的非急诊患者中使用连接到 CPB 电路的非选择性 EBP 设备与术后头 7 天 CSA-AKI 的显著降低有关:试验注册:ClinicalTrials.gov Identifier:试验注册:ClinicalTrials.gov Identifier:NCT02518087。
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Extracorporeal Blood Purification and Acute Kidney Injury in Cardiac Surgery: The SIRAKI02 Randomized Clinical Trial.

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.

Trial registration: ClinicalTrials.gov Identifier: NCT02518087.

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期刊介绍: JAMA, published continuously since 1883, is an international peer-reviewed general medical journal. JAMA is a member of the JAMA Network, a consortium of peer-reviewed, general medical and specialty publications.
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