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Study protocol: The DOse REsponse Multicentre International collaborative initiative (DO-RE-MI)

机译:研究方案:DOse REsponse多中心国际协作计划(DO-RE-MI)

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IntroductionCurrent practices for renal replacement therapy in intensive care units (ICUs) remain poorly defined. The DOse REsponse Multicentre International collaborative initiative (DO-RE-MI) will address the issue of how the different modes of renal replacement therapy are currently chosen and performed. Here, we describe the study protocol, which was approved by the Scientific and Steering Committees.MethodsDO-RE-MI is an observational, multicentre study conducted in ICUs. The primary end-point will be the delivered dose of dialysis, which will be compared with ICU mortality, 28-day mortality, hospital mortality, ICU length of stay and number of days of mechanical ventilation. The secondary end-point will be the haemodynamic response to renal replacement therapy, expressed as percentage reduction in noradrenaline (norepinephrine) requirement. Based on the the sample analysis calculation, at least 162 patients must be recruited. Anonymized patient data will be entered online in electronic case report forms and uploaded to an internet website. Each participating centre will have 2 months to become acquainted with the electronic case report forms. After this period official recruitment will begin. Patient data belong to the respective centre, which may use the database for its own needs. However, all centres have agreed to participate in a joint effort to achieve the sample size needed for statistical analysis.ConclusionThe study will hopefully help to collect useful information on the current practice of renal replacement therapy in ICUs. It will also provide a centre-based collection of data that will be useful for monitoring all aspects of extracorporeal support, such as incidence, frequency, and duration.
机译:简介目前在重症监护病房(ICU)中进行肾脏替代疗法的实践还不清楚。 DOse REsponse国际多中心合作倡议(DO-RE-MI)将解决当前如何选择和执行不同形式的肾脏替代疗法的问题。在这里,我们描述了由科学和指导委员会批准的研究方案。方法DO-RE-MI是在ICU中进行的一项观察性,多中心研究。主要终点是透析的剂量,将其与ICU死亡率,28天死亡率,医院死亡率,ICU住院时间和机械通气天数进行比较。次要终点是对肾脏替代疗法的血流动力学反应,表示为降低去甲肾上腺素(去甲肾上腺素)所需量的百分比。根据样本分析计算,必须至少招募162名患者。匿名患者数据将以电子病例报告形式在线输入并上传到互联网网站。每个参与中心将有两个月的时间了解电子病例报告表。在此之后,将开始正式招聘。患者数据属于各自的中心,后者可以根据自己的需要使用数据库。但是,所有研究中心都同意共同努力,以达到进行统计分析所需的样本量。结论这项研究有望帮助收集有关当前在ICU中进行肾脏替代治疗的有用信息。它还将提供基于中心的数据收集,这对于监视体外支持的各个方面(例如发生率,频率和持续时间)将很有用。

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