在脓毒性休克患者中使用体外血液净化疗法和序贯体外支持(EROICASS):一项全国性、非干预性、多中心观察性、前瞻性研究的研究方案。

Silvia De Rosa, Fiorenza Ferrari, Massimiliano Greco, Vincenzo Pota, Michele Umbrello, Antonella Cotoia, Laura Pasin, Federico Nalesso, Gianluca Paternoster, Gianluca Villa, Sergio Lassola, Sara Miori, Andrea Sanna, Vicenzo Cantaluppi, Marita Marengo, Fabrizio Valente, Marco Fiorentino, Giuliano Brunori, Giacomo Bellani, Antonino Giarratano
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引用次数: 0

摘要

背景:脓毒性休克是一种以器官功能衰竭为特征的危重病症,在重症监护病房(ICU)中有很大的死亡风险,28 天的死亡率可能高达 40%。脓毒性休克的传统治疗方法通常包括使用抗生素、对器官功能障碍进行支持性护理,必要时还需进行手术干预以消除感染源。近几十年来,体外血液净化疗法(EBPT)已成为一种潜在的干预措施,旨在调节脓毒症患者的炎症反应并恢复体内平衡。同样,脓毒症序贯体外疗法(SETS)干预措施可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研究将评估和描述脓毒性休克患者使用体外碎石疗法的情况。此外,我们还将评估意大利脓毒性休克病例中 EBPT 治疗利用率与 90 天死亡率之间的潜在关联:EROICASS研究是一项全国性、非干预性、多中心前瞻性队列观察研究。参与研究的中心将对所有连续的脓毒性休克患者进行前瞻性登记,收集从重症监护室(ICU)入院到出院期间的数据。患者的人口统计学特征、临床参数、EBPT/SETS 使用情况和治疗效果等变量将通过网络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 使用情况与患者预后之间的关联:EROICASS研究为了解脓毒性休克治疗中EBPT和SETS的使用情况和结果提供了宝贵的信息。通过分析使用模式和临床数据,该研究旨在指导治疗决策和加强患者护理。这些发现的意义可能会影响临床指南,从而有可能提高脓毒性休克病例的存活率和患者预后。
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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.

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.

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