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脓毒性休克患者体外血液净化疗法及序贯体外支持的应用(EROICASS):一项全国性、非介入性、观察性多中心前瞻性研究方案

The use of extracorporeal blood purification therapies and sequential extracorporeal support in patients with septic shock (EROICASS): a study protocol for a national, non-interventional, observational multicenter, prospective study.

作者信息

De Rosa Silvia, Ferrari Fiorenza, Greco Massimiliano, Pota Vincenzo, Umbrello Michele, Cotoia Antonella, Pasin Laura, Nalesso Federico, Paternoster Gianluca, Villa Gianluca, Lassola Sergio, Miori Sara, Sanna Andrea, Cantaluppi Vicenzo, Marengo Marita, Valente Fabrizio, Fiorentino Marco, Brunori Giuliano, Bellani Giacomo, Giarratano Antonino

机构信息

Centre for Medical Sciences (CISMed), University of Trento, 38122, Trento, Italy.

Anaesthesia and Intensive Care, Santa Chiara Regional Hospital, APSS, Trento, Italy.

出版信息

J Anesth Analg Crit Care. 2024 Feb 26;4(1):16. doi: 10.1186/s44158-024-00153-7.

Abstract

BACKGROUND

Septic shock, a critical condition characterized by organ failure, presents a substantial mortality risk in intensive care units (ICUs), with the 28-day mortality rate possibly reaching 40%. Conventional management of septic shock typically involves the administration of antibiotics, supportive care for organ dysfunction, and, if necessary, surgical intervention to address the source of infection. In recent decades, extracorporeal blood purification therapies (EBPT) have emerged as potential interventions aimed at modulating the inflammatory response and restoring homeostasis in patients with sepsis. Likewise, sequential extracorporeal therapy in sepsis (SETS) interventions offer comprehensive organ support in the setting of multiple organ dysfunction syndrome (MODS). The EROICASS study will assess and describe the utilization of EBPT in patients with septic shock. Additionally, we will evaluate the potential association between EBPT treatment utilization and 90-day mortality in septic shock cases in Italy.

METHODS

The EROICASS study is a national, non-interventional, multicenter observational prospective cohort study. All consecutive patients with septic shock at participating centers will be prospectively enrolled, with data collection extending from intensive care unit (ICU) admission to hospital discharge. Variables including patient demographics, clinical parameters, EBPT/SETS utilization, and outcomes will be recorded using a web-based data capture system. Statistical analyses will encompass descriptive statistics, hypothesis testing, multivariable regression models, and survival analysis to elucidate the associations between EBPT/SETS utilization and patient outcomes.

CONCLUSIONS

The EROICASS study provides valuable insights into the utilization and outcomes of EBPT and SETS in septic shock management. Through analysis of usage patterns and clinical data, this study aims to guide treatment decisions and enhance patient care. The implications of these findings may impact clinical guidelines, potentially improving survival rates and patient outcomes in septic shock cases.

摘要

背景

感染性休克是一种以器官功能衰竭为特征的危急病症,在重症监护病房(ICU)中具有很高的死亡风险,28天死亡率可能达到40%。感染性休克的传统治疗通常包括使用抗生素、对器官功能障碍进行支持治疗,以及在必要时进行手术干预以解决感染源。近几十年来,体外血液净化疗法(EBPT)已成为旨在调节脓毒症患者炎症反应并恢复体内平衡的潜在干预措施。同样,脓毒症序贯体外治疗(SETS)干预措施在多器官功能障碍综合征(MODS)的情况下提供全面的器官支持。EROICASS研究将评估和描述EBPT在感染性休克患者中的应用情况。此外,我们将评估意大利感染性休克病例中EBPT治疗应用与90天死亡率之间的潜在关联。

方法

EROICASS研究是一项全国性、非干预性、多中心观察性前瞻性队列研究。参与中心的所有连续感染性休克患者将被前瞻性纳入研究,数据收集从重症监护病房(ICU)入院延伸至出院。包括患者人口统计学、临床参数、EBPT/SETS应用情况和结局等变量将使用基于网络的数据采集系统进行记录。统计分析将包括描述性统计、假设检验、多变量回归模型和生存分析,以阐明EBPT/SETS应用与患者结局之间的关联。

结论

EROICASS研究为EBPT和SETS在感染性休克管理中的应用及结局提供了有价值的见解。通过分析使用模式和临床数据,本研究旨在指导治疗决策并改善患者护理。这些发现的意义可能会影响临床指南,有可能提高感染性休克病例的生存率和患者结局。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a93d/10898122/cb5655625f96/44158_2024_153_Fig1_HTML.jpg

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