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体外心肺复苏后心脏停搏综合征患者的细胞因子吸附(CYTER)——一项单中心、开放标签、随机、对照试验。

Cytokine adsorption in patients with post-cardiac arrest syndrome after extracorporeal cardiopulmonary resuscitation (CYTER) - A single-centre, open-label, randomised, controlled trial.

机构信息

Department of Medicine III (Interdisciplinary Medical Intensive Care), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany; Department of Cardiology and Angiology I, Heart Center, University of Freiburg, Germany; Heidelberg Institute of Global Health, University of Heidelberg, Germany.

Department of Medicine III (Interdisciplinary Medical Intensive Care), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany; Department of Cardiology and Angiology I, Heart Center, University of Freiburg, Germany.

出版信息

Resuscitation. 2022 Apr;173:169-178. doi: 10.1016/j.resuscitation.2022.02.001. Epub 2022 Feb 7.

Abstract

AIM

To investigate the effect of cytokine adsorption in patients receiving extracorporeal cardiopulmonary resuscitation (ECPR) after cardiac arrest.

METHODS

CYTER was a single-centre, open-label, randomised, controlled trial. Patients selected for ECPR at the University Medical Center Freiburg (Freiburg, Germany) were assigned to extracorporeal membrane oxygenation (ECMO) support with or without cytokine adsorption (1:1) using the CytoSorb adsorber, incorporated into the ECMO, replaced every 24 hours, and removed after 72 hours. The primary endpoint was serum interleukin (IL)-6 concentration at 72 hours (intention-to-treat analysis). Secondary endpoints included 30-day survival, vasopressor support and biomarkers of end-organ injury.

RESULTS

Of 50 patients enrolled in the trial, 26 (52%) were treated with cytokine adsorption and 24 (48%) without. Nine patients were excluded (informed consent could not be obtained); 41 patients were therefore included in the primary analysis. Median IL-6 levels (IQR) decreased from 408.0(93.4-906.5) to 324.0 (134.3-4617.3) pg/mL and increased from 133.0 (56.2-528.5) to 241.0 (132.8-718.0) pg/mL in the cytokine adsorption and control group, respectively (linear regression for treatment [cytokine adsorption vs control]: p = 0.48). Three (14%) of 22 patients treated with cytokine adsorption and 8 (42%) of 19 patients treated without cytokine adsorption survived to day 30 (HR = 1.85, 95% CI 0.86-4.01; p = 0.10). Vasopressor support and NSE, S100b, troponin T, CRP and PCT levels were similar between groups.

CONCLUSION

Cytokine adsorption in patients receiving ECPR did not reduce serum IL-6 and had no significant effect on survival, vasopressor support, or biomarkers of injury.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov: NCT03685383.

摘要

目的

研究细胞因子吸附在心脏骤停后接受体外心肺复苏(ECPR)的患者中的作用。

方法

CYTER 是一项单中心、开放标签、随机对照试验。德国弗赖堡大学医学中心(弗赖堡)选择进行 ECPR 的患者,使用 CytoSorb 吸附剂(一种纳入 ECMO 的体外膜氧合支持)进行 1:1 分组,每 24 小时更换一次,72 小时后去除。主要终点是 72 小时时血清白细胞介素(IL)-6 浓度(意向治疗分析)。次要终点包括 30 天存活率、血管加压支持和靶器官损伤的生物标志物。

结果

在这项试验中,50 名入组患者中,26 名(52%)接受细胞因子吸附治疗,24 名(48%)未接受。9 名患者被排除(无法获得知情同意);因此,41 名患者被纳入主要分析。中位数 IL-6 水平(IQR)从 408.0(93.4-906.5)降至 324.0(134.3-4617.3)pg/ml,并从 133.0(56.2-528.5)增至 241.0(132.8-718.0)pg/ml,分别在细胞因子吸附组和对照组(治疗的线性回归:p=0.48)。22 名接受细胞因子吸附治疗的患者中有 3 名(14%)和 19 名未接受细胞因子吸附治疗的患者中有 8 名(42%)存活至第 30 天(HR=1.85,95%CI 0.86-4.01;p=0.10)。血管加压支持和 NSE、S100b、肌钙蛋白 T、CRP 和 PCT 水平在两组之间相似。

结论

接受 ECPR 的患者进行细胞因子吸附并未降低血清 IL-6 水平,对存活率、血管加压支持或损伤生物标志物也没有显著影响。

临床试验注册

ClinicalTrials.gov:NCT03685383。

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