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使用奥西里斯膜进行心脏手术时细胞因子血液吸附与标准治疗的比较:OXICARD单中心随机试验

Cytokine Hemoadsorption versus Standard Care in Cardiac Surgery Using the Oxiris Membrane: The OXICARD Single-center Randomized Trial.

作者信息

Abou-Arab Osama, Huette Pierre, Ibrahima Azrat, Beyls Christophe, Bayart Guillaume, Guilbart Mathieu, Coupez Adrien, Bennis Youssef, Navarre Aurélie, Lenglet Gaelle, Béal Roman, Touati Gilles, Caus Thierry, Bar Stéphane, Josse Estelle, Nguyen Maxime, Dupont Hervé, Gubler Brigitte, Kamel Saïd, Diouf Momar, Mahjoub Yazine

机构信息

Anesthesia and Critical Care Department, Amiens University Hospital, Amiens, France; EA7517, Pathophysiological Mechanisms and Consequences of Cardiovascular Calcifications (MP3CV), Jules Verne University of Picardie, Amiens, France.

Anesthesia and Critical Care Department, Amiens University Hospital, Amiens, France.

出版信息

Anesthesiology. 2025 May 1;142(5):874-884. doi: 10.1097/ALN.0000000000005376. Epub 2025 Jan 21.

DOI:10.1097/ALN.0000000000005376
PMID:39841886
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11974623/
Abstract

BACKGROUND

Cardiac surgery can lead to dysregulation with a proinflammatory state, resulting in adverse outcomes. Hemadsorption using the AN-69 membrane (Oxiris membrane, Baxter, USA) has the properties to chelate inflammatory cytokines. The authors hypothesized that in patients at high risk of inflammation, the use of the Oxiris membrane could decrease inflammation, preserve endothelial function, and improve postoperative outcomes.

METHODS

The authors conducted a randomized single-center study at Amiens University Hospital (Amiens, France). The study population consisted of adult patients admitted for scheduled cardiac surgery with an expected cardiopulmonary bypass (CPB) time greater than 90 min. The patients were allocated to either the standard group or the Oxiris group. The intervention consisted of using the Oxiris membrane on a Prismaflex device (Baxter, USA) at a blood flow rate of 450 ml/min during CPB. The primary outcome was the assessment of microcirculation on day 1 after surgery by measuring sublingual microcirculation using the microvascular flow index. Microvascular flow index reflects the microcirculation flow type and is graded from 0 to 3 as follows: 0, no flow; 1, intermittent flow; 2, sluggish flow; 3, continuous flow. The secondary outcome was a composite adverse outcome within 30 days after surgery. Cytokines and endothelial biomarkers were measured in all patients at different time points. An intention-to-treat analysis was performed.

RESULTS

From October 2019 to November 2022, the study included 70 patients. Two patients were excluded from the Oxiris group: one patient did not undergo surgery, and one procedure was performed under deep hypothermia. The microvascular flow index did not differ between groups on day 1 from baseline: difference (95% CI) Oxiris minus standard at -0.17 (-0.44 to 0.10); P = 0.2. The occurrence of a composite adverse outcome did not significantly differ between groups (14 [42%] for the Oxiris group vs. 12 [35%] for the standard group; P = 0.7). The overall variation in cytokines and angiopoietins did not significantly differ between groups.

CONCLUSIONS

In patients scheduled for a cardiac surgery with prolonged CPB, the authors could not demonstrate the benefit on microcirculation and major cardiovascular events.

摘要

背景

心脏手术可导致炎症状态失调,从而产生不良后果。使用AN - 69膜(美国百特公司的Oxiris膜)进行血液吸附具有螯合炎性细胞因子的特性。作者推测,对于有高炎症风险的患者,使用Oxiris膜可减轻炎症、保护内皮功能并改善术后结局。

方法

作者在法国亚眠大学医院进行了一项随机单中心研究。研究对象为计划进行心脏手术且预期体外循环(CPB)时间超过90分钟的成年患者。患者被分配至标准组或Oxiris组。干预措施为在CPB期间以450毫升/分钟的血流速度在Prismaflex设备(美国百特公司)上使用Oxiris膜。主要结局是术后第1天通过使用微血管血流指数测量舌下微循环来评估微循环。微血管血流指数反映微循环血流类型,分级为0至3级,如下:0级,无血流;1级,间歇性血流;2级,血流缓慢;3级,持续血流。次要结局是术后30天内的复合不良结局。在所有患者的不同时间点测量细胞因子和内皮生物标志物。进行意向性分析。

结果

从2019年10月至2022年11月,该研究纳入70例患者。Oxiris组排除2例患者:1例患者未接受手术,1例手术在深度低温下进行。术后第1天两组间微血管血流指数与基线相比无差异:Oxiris组减去标准组的差值(95%可信区间)为-0.17(-0.44至0.10);P = 0.2。两组间复合不良结局的发生率无显著差异(Oxiris组为14例[42%],标准组为12例[35%];P = 0.7)。两组间细胞因子和血管生成素的总体变化无显著差异。

结论

对于计划进行CPB时间延长的心脏手术患者,作者未能证明使用Oxiris膜对微循环和主要心血管事件有获益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6261/11974623/bfc61e115c4e/aln-142-874-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6261/11974623/1c61ba0f053c/aln-142-874-g001.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6261/11974623/b79e0ec49164/aln-142-874-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6261/11974623/b698350c7816/aln-142-874-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6261/11974623/bfc61e115c4e/aln-142-874-g004.jpg

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本文引用的文献

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Cytokine Hemoadsorption During Cardiac Surgery Versus Standard Surgical Care for Infective Endocarditis (REMOVE): Results From a Multicenter Randomized Controlled Trial.心脏手术中细胞因子血液吸附与感染性心内膜炎标准手术治疗的比较(REMOVE):多中心随机对照试验的结果。
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