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oXirisNet注册研究:一项关于oXiris膜的前瞻性全国性注册研究。

oXirisNet Registry: A Prospective, National Registry on the oXiris Membrane.

作者信息

Villa Gianluca, De Rosa Silvia, Samoni Sara, Neri Mauro, Cosimo Chelazzi, Romagnoli Stefano, Gavagni Mattia, Ronco Claudio, De Gaudio A Raffaele

机构信息

Department of Health Sciences, Section of Anesthesiology and Intensive Care, University of Florence, Florence, Italy.

Department of Anesthesia and Intensive Care, Section of Oncological Anesthesia and Intensive Care, Azienda Ospedaliero Universitaria Careggi, Florence, Italy.

出版信息

Blood Purif. 2019 Apr 11;47 Suppl 3:1-8. doi: 10.1159/000499356.

Abstract

Worldwide, the widespread use of extracorporeal blood purification therapies (EBPTs) is progressively increasing in everyday clinical practice, particularly in critical care settings. The efficacy of EBPTs on removal of inflammatory mediators is already well established in the literature. Nonetheless, clinical research is particularly cumbersome in this setting, and many clinical trials aiming at exploring the effect of EBPTs on outcomes have failed in demonstrating consistent results regarding 28-day- or hospital-mortality rates. In recent years, data emerging from large registries have been increasingly used to provide real-world evidence on the effectiveness, quality, and safety of EBPTs. The philosophy behind this Italian Registry is a renewal of the concept of "clinical research" in the field of EBPTs applied to critically ill, septic patients with or without acute kidney injury. The platform used for the registry - specifically designed for research purposes and fed by clinical data prospectively observed - promotes good practice with a positive and active interaction with the physician/researcher. This interaction has favorable real-time effects for the specific patient, providing "bed-side clinical feedbacks," similarly to the decision support system. Examples of these issues are bundles reminders, suggestions for drug adjustment according to the extracorporeal clearance, clinical calculator for body mass index, or mechanical ventilation setting. The platform-physician interaction has additional useful effects on the single utilizing center, providing "mid-term, center-specific clinical feedbacks." These generally consist of clusters of data taken over a certain period, for example, regarding patients' outcome, microbiological data, or use of disposable for EBPTs.

摘要

在全球范围内,体外血液净化疗法(EBPTs)在日常临床实践中的广泛应用正日益增加,尤其是在重症监护环境中。EBPTs对炎症介质清除的疗效在文献中已得到充分证实。尽管如此,在这种情况下临床研究特别繁琐,许多旨在探索EBPTs对预后影响的临床试验未能在28天死亡率或医院死亡率方面取得一致结果。近年来,大型注册研究中出现的数据越来越多地被用于提供关于EBPTs有效性、质量和安全性的真实世界证据。这个意大利注册研究背后的理念是对应用于患有或未患有急性肾损伤的重症脓毒症患者的EBPTs领域中“临床研究”概念的更新。用于该注册研究的平台——专门为研究目的设计并以前瞻性观察到的临床数据为支撑——通过与医生/研究人员进行积极有效的互动来促进良好实践。这种互动对特定患者具有实时的有利影响,提供“床边临床反馈”,类似于决策支持系统。这些问题的例子包括集束提醒、根据体外清除率调整药物的建议、体重指数临床计算器或机械通气设置。平台与医生的互动对单个使用中心还有其他有益影响,提供“中期、特定中心的临床反馈”。这些反馈通常由一段时间内收集的数据集群组成,例如关于患者的预后、微生物学数据或EBPTs一次性用品的使用情况。

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