《COSMOS 细胞吸附治疗危重症患者的注册研究：一项国际性前瞻性注册研究方案》

The COSMOS Registry of CytoSorb Hemoadsorption Therapy in Critically Ill Patients: Protocol for an International, Prospective Registry.

机构信息

Department of Intensive Care, Hôpital Universitaire de Bruxelles (HUB), Université Libre de Bruxelles (ULB), Brussels, Belgium.

Integriertes Forschungs- und Behandlungszentrum (IFB) Sepsis und Sepsisfolgen, Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Jena, Jena, Germany.

出版信息

JMIR Res Protoc. 2024 Nov 5;13:e55880. doi: 10.2196/55880.

DOI:10.2196/55880

PMID:39500494

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11576605/

Abstract

BACKGROUND

Extracorporeal blood purification with CytoSorb has been increasingly used as an adjunctive therapy in several hyperinflammatory critical care conditions, as well as to remove elevated levels of myoglobin or bilirubin in patients with rhabdomyolysis or liver failure. Despite the increasing worldwide use of hemoadsorption, data from large international multicenter studies are still lacking.

OBJECTIVE

The COSMOS (CytoSorb Treatment Of Critically Ill Patients) registry is a company-sponsored registry by CytoSorbents Corporation and CytoSorbents Medical Inc. and will provide a data repository and reporting infrastructure for the surveillance of CytoSorb use in real-world critical care settings in an unselected, critically ill patient population. The gathered data will serve as a comprehensive resource to assess the effects of such therapy on patients' management.

METHODS

The international COSMOS registry is collecting prospective data for patients treated with CytoSorb during routine care in various critical care indications, based on the decision of the treating physicians. Data are collected at baseline, during CytoSorb therapy, 24 hours thereafter, at discharge from the intensive care unit and the hospital, and on day 90. Key outcomes assessed include change in inflammatory biomarkers, vasopressor requirements, fluid balance, organ function and organ support, length of intensive care unit and hospital stay, occurrence of adverse events, and mortality.

RESULTS

The COSMOS registry started with the inclusion of the first patient on July 15, 2022, and is now actively enrolling in 4 countries (Germany, Spain, Portugal, and Italy), with plans to expand to other countries outside of Europe. An initial readout is planned for presentation at an international Critical Care conference in 2024.

CONCLUSIONS

The COSMOS registry is intended to provide comprehensive real-world data on patient outcomes with CytoSorb in various critical care indications, thereby contributing to optimization of patient selection, timing of initiation, and dosing of hemoadsorption treatment.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05146336; https://clinicaltrials.gov/study/NCT05146336.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55880.

摘要

背景

细胞吸附剂体外血液净化（CytoSorb）已越来越多地被用作多种炎症性危重病况的辅助治疗方法，以及用于去除横纹肌溶解症或肝功能衰竭患者中升高的肌红蛋白或胆红素水平。尽管全球范围内越来越多地使用血液吸附，但仍缺乏来自大型国际多中心研究的数据。

目的

COS-MOS（CytoSorb 治疗危重症患者）登记研究是 CytoSorbents 公司和 CytoSorbents Medical Inc. 赞助的一项公司登记研究，将为在未选择的危重症患者人群中，在真实临床环境中使用 CytoSorb 的监测提供一个数据存储库和报告基础设施。收集的数据将作为评估此类治疗对患者管理影响的综合资源。

方法

国际 COSMOS 登记研究正在根据治疗医生的决定，为接受 CytoSorb 常规治疗的各种危重症患者前瞻性收集数据。数据在基线时、CytoSorb 治疗期间、之后 24 小时、从重症监护病房和医院出院时以及第 90 天收集。评估的关键结局包括炎症生物标志物变化、血管加压药需求、液体平衡、器官功能和器官支持、重症监护病房和住院时间、不良事件发生和死亡率。