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在接受 VV ECMO 的危重症 COVID-19 患者中进行体外血液吸附:COVID-19 中的 CytoSorb 治疗(CTC)登记研究。

Extracorporeal hemoadsorption in critically ill COVID-19 patients on VV ECMO: the CytoSorb therapy in COVID-19 (CTC) registry.

机构信息

Department of Cardiovascular and Thoracic Surgery, West Virginia University, 1 Medical Center Drive, Morgantown, WV, 26506, USA.

University of Chicago Medicine, Chicago, USA.

出版信息

Crit Care. 2023 Jun 19;27(1):243. doi: 10.1186/s13054-023-04517-3.

Abstract

OBJECTIVES

The CytoSorb therapy in COVID-19 (CTC) registry evaluated the clinical performance and treatment parameters of extracorporeal hemoadsorption integrated with veno-venous extracorporeal membrane oxygenation (VV ECMO) in critically ill COVID-19 patients with acute respiratory distress syndrome (ARDS) and respiratory failure under US FDA Emergency Use Authorization.

DESIGN

Multicenter, observational, registry (NCT04391920).

SETTING

Intensive care units (ICUs) in five major US academic centers between April 2020 and January 2022.

PATIENTS

A total of 100 critically ill adults with COVID-19-related ARDS requiring VV ECMO support, who were treated with extracorporeal hemoadsorption.

INTERVENTIONS

None.

MEASUREMENTS AND MAIN RESULTS

Baseline demographics, clinical characteristics, laboratory values and outcomes were recorded following individual ethics committee approval at each center. Detailed data on organ support utilization parameters and hemoadsorption treatments were also collected. Biomarker data were collected according to the standard practice at each participating site, and available values were compared before and after hemoadsorption. The primary outcome of mortality was evaluated using a time-to-event analysis. A total of 100 patients (63% male; age 44 ± 11 years) were included. Survival rates were 86% at 30 days and 74% at 90 days. Median time from ICU admission to the initiation of hemoadsorption was 87 h and was used to define two post hoc groups: ≤ 87 h (group-early start, G) and > 87 h (group-late start, G). After the start of hemoadsorption, patients in the G versus G had significantly shorter median duration of mechanical ventilation (7 [2-26] vs. 17 [7-37] days, p = 0.02), ECMO support (13 [8-24] vs. 29 [14-38] days, p = 0.021) and ICU stay (17 [10-40] vs 36 [19-55] days, p = 0.002). Survival at 90 days in G was 82% compared to 66% in G (p = 0.14). No device-related adverse events were reported.

CONCLUSIONS

In critically ill patients with severe COVID-19-related ARDS treated with the combination of VV-ECMO and hemoadsorption, 90-day survival was 74% and earlier intervention was associated with shorter need for organ support and ICU stay. These results lend support to the concept of "enhanced lung rest" with the combined use of VV-ECMO plus hemoadsorption in patients with ARDS.

摘要

目的

COVID-19 中的 CytoSorb 治疗(CTC)登记研究评估了在获得美国食品药品监督管理局(FDA)紧急使用授权下,体外血液吸附与静脉-静脉体外膜肺氧合(VV ECMO)联合应用于伴有急性呼吸窘迫综合征(ARDS)和呼吸衰竭的危重症 COVID-19 患者中的临床性能和治疗参数。

设计

多中心、观察性、登记研究(NCT04391920)。

地点

2020 年 4 月至 2022 年 1 月在美国五个主要学术中心的重症监护病房(ICU)。

患者

共纳入 100 例因 COVID-19 相关 ARDS 而需要 VV ECMO 支持的危重症成年人,他们接受了体外血液吸附治疗。

干预措施

无。

测量和主要结果

在每个中心的单独伦理委员会批准后,记录了基线人口统计学、临床特征、实验室值和结局。还收集了有关器官支持利用参数和血液吸附治疗的详细数据。生物标志物数据按照每个参与地点的标准操作进行收集,并比较了血液吸附前后的可用值。使用时间到事件分析评估死亡率这一首要结局。共纳入 100 例患者(63%为男性;年龄 44±11 岁)。30 天的生存率为 86%,90 天的生存率为 74%。从 ICU 入院到开始血液吸附的中位时间为 87 小时,用于定义两个事后组:≤87 小时(组-早期开始,G)和>87 小时(组-晚期开始,G)。在开始血液吸附后,G 组与 G 组相比,机械通气(7[2-26]与 17[7-37]天,p=0.02)、ECMO 支持(13[8-24]与 29[14-38]天,p=0.021)和 ICU 住院时间(17[10-40]与 36[19-55]天,p=0.002)的中位持续时间明显缩短。G 组 90 天的生存率为 82%,G 组为 66%(p=0.14)。未报告与设备相关的不良事件。

结论

在接受 VV-ECMO 和血液吸附联合治疗的伴有严重 COVID-19 相关 ARDS 的危重症患者中,90 天生存率为 74%,较早的干预与器官支持和 ICU 住院时间缩短相关。这些结果支持在 ARDS 患者中联合使用 VV-ECMO 加血液吸附以实现“增强肺休息”的概念。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b444/10280833/c5f87181dccd/13054_2023_4517_Fig1_HTML.jpg

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