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中德脓毒症队列研究(MSC):一项脓毒症存活者的前瞻性观察研究。

Mid-German Sepsis Cohort (MSC): a prospective observational study of sepsis survivorship.

机构信息

Integrated Research and Treatment Center, Center for Sepsis Control and Care (CSCC), Jena University Hospital, Jena, Germany.

Research Group Clinical Epidemiology, CSCC, Jena University Hospital, Jena, Germany.

出版信息

BMJ Open. 2021 Mar 17;11(3):e043352. doi: 10.1136/bmjopen-2020-043352.

Abstract

PURPOSE

The Mid-German Sepsis Cohort (MSC) aims to investigate mid-term and long-term functional disabilities in sepsis survivors from intensive care unit (ICU) discharge until 1 year after. Secondary, post-acute mortality and morbidity, health-related quality of life and healthcare utilisation will be investigated.

PARTICIPANTS

The MSC comprises adult (aged ≥18 years) patients who were treated for (severe) sepsis or septic shock on ICU. The participants were recruited between 15 April 2016 and 30 November 2018 from five German centres. Three thousand two hundred and ten patients with sepsis were identified, of which 1968 survived their ICU stay and were eligible for enrolment in the follow-up cohort. Informed consent for follow-up assessment was provided by 907 patients (46.1% of eligible patients).

FINDINGS TO DATE

The recruitment of the participants for follow-up assessments and the baseline data collection is completed. Incidence of sepsis was 116.7 patients per 1000 ICU patients. In this cohort profile, we provide an overview of the demographics and the clinical characteristics of both the overall sepsis cohort and the ICU survivors who provided informed consent for follow-up assessment (907 out of 1968 ICU survivors (46.1%)).

FUTURE PLANS

The follow-ups are conducted 3, 6 and 12 months after ICU discharge. Another yearly follow-up up to 5 years after ICU discharge is pursued. Several cooperation and satellite projects were initiated. This prospective cohort offers a unique resource for research on long-term sequelae of sepsis survivors.

TRIAL REGISTRATION NUMBER

German Clinical Trials Registry (DRKS00010050).

摘要

目的

中德脓毒症队列(MSC)旨在调查从重症监护病房(ICU)出院到 1 年后脓毒症幸存者的中期和长期功能障碍。其次,将调查急性后期死亡率和发病率、健康相关生活质量和医疗保健利用情况。

参与者

MSC 包括在 ICU 接受(严重)脓毒症或脓毒性休克治疗的成年(年龄≥18 岁)患者。参与者于 2016 年 4 月 15 日至 2018 年 11 月 30 日从五个德国中心招募。确定了 3210 名脓毒症患者,其中 1968 名患者在 ICU 期间存活并符合纳入随访队列的条件。907 名(符合条件患者的 46.1%)患者同意进行随访评估。

迄今为止的发现

已完成对参与者进行随访评估和基线数据收集的招募工作。ICU 患者中脓毒症的发病率为每 1000 名患者中有 116.7 名。在本队列简介中,我们提供了总体脓毒症队列和同意进行随访评估的 ICU 幸存者(1968 名 ICU 幸存者中的 907 名(46.1%))的人口统计学和临床特征概述。

未来计划

在 ICU 出院后 3、6 和 12 个月进行随访。还进行了另一次每年一次的随访,直至 ICU 出院后 5 年。已经启动了几个合作和卫星项目。这个前瞻性队列为研究脓毒症幸存者的长期后遗症提供了一个独特的资源。

试验注册

德国临床试验注册处(DRKS00010050)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0666/7978081/49e70293f926/bmjopen-2020-043352f01.jpg

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