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Epidemiology of Acute Respiratory Distress Syndrome in Chinese ICUs

2020年6月13日 更新者:Peking Union Medical College Hospital
The acute respiratory distress syndrome(ARDS)has a high morbidity and mortality in patients admitted to intensive care units(ICUs). It represents a significant public health issue. No large nationwide, multicenters study of ARDS has been conducted in China. The purposes of this study are to analyse: 1)the incidence and outcomes of ARDS in ICU; 2) factors associated the mortality ; and 3) risk factors for development of ARDS .

研究概览

地位

完全的

详细说明

All patients admitted to the participating ICUs during a 6-month period(from January 1, 2015 to July 1,2015 ) will be screened at ICU admission and daily for the occurrence of ARDS ( AECC criteria) for a maximum of 28 days after ICU admission.

Data collection:

  1. For all patients, Demographic characteristics, admission category, the patient source intervention during ICU , APACHEII , SOFA score and discharge information will be collected
  2. For patients with ARDS, data about ABG , parameters of MV, hemodynamic on day0 to day7 and last day of MV will be collected.
  3. For patients without ARDS at ICU admission, data about risk factor for ARDS ,such as LIPS score, parameters of MV , and fluid balance on ICU day0 to day7 will be collected.

研究类型

观察性的

注册 (实际的)

2530

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Beijing
      • Beijing、Beijing、中国
        • Peking University People's Hospital
      • Beijing、Beijing、中国、100730
        • MICU, Peking union medical college hospital
      • Beijing、Beijing、中国
        • Beijing Hospital of Ministry of Health
      • Beijing、Beijing、中国
        • Department of Critical Care Medicine, Fuxing Hospital, Capital Medical University
      • Beijing、Beijing、中国
        • General ICU, Beijing Tongren Hospital, Capital Medical University
      • Beijng、Beijing、中国
        • China-Japan Friendship Hospital
    • Chongqing
      • ChongQing、Chongqing、中国
        • Department of Emergency and Intensive Care Medicine, The First Affiliated Hospital of Chongqing Medical University
    • Fujian
      • Fuzhou、Fujian、中国
        • The First Affiliated Hospital Of Fujian Medical University
    • Guangdong
      • Guangzhou、Guangdong、中国
        • Department of CriticalCare Medicine, Guangdong General Hospital
    • Hainan
      • HaiKou、Hainan、中国
        • Department of Critical Care Medicine, Hainan Provincial People's Hospital
    • Hebei
      • Shijiazhuang、Hebei、中国
        • Department of Critical Care Medicine, Hebei Medical University Fourth Hospital
    • Heilongjiang
      • Harbin、Heilongjiang、中国
        • Department of Critical Care Medicine, The First Affiliated Hospital of Harbin Medical University
    • Henan
      • Zhengzhou、Henan、中国
        • ICU, The First Affiliated Hospital, Zhengzhou University
    • Hubei
      • WuHan、Hubei、中国
        • Department of Critical Care Medicine, Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology
    • Hunan
      • Changsha、Hunan、中国
        • Department of Critical Care Medicine, Xiangya Hospital, Central South University
    • Inner Mongolia
      • Hohhot、Inner Mongolia、中国
        • Department of Critical Care Medicine, The Affiliated Hopsital of Inner Mongolia Medical University
    • Jilin
      • ChangChun、Jilin、中国
        • Department of Critical Care Medicine, The Second Hospital of Jilin University
    • Liaoning
      • Shenyang、Liaoning、中国
        • Department of Critical Care Medicine, The First Affiliated Hospital of China Medical University
    • Ningxia
      • YinChuan、Ningxia、中国
        • General Hospital of Ningxia Medical University
    • Shandong
      • Jinan、Shandong、中国
        • Department of Critical Care Medicine, Qilu Hospital of Shandong University
    • Shanghai
      • Shanghai、Shanghai、中国
        • Emergency ICU, Ruijin Hospital, Shanghai Jiao Tong University
    • Shanxi
      • XiAn、Shanxi、中国
        • Surgical Intensive Care Unit, Xijing Hospital
    • Sichuan
      • Chengdu、Sichuan、中国
        • Department of Critical Care Medicine, West China Hospital, Sichuan University
    • Xinjiang
      • Urumqi、Xinjiang、中国
        • Department of Critical Care Medicine, First Affiliated Hospital, Xinjiang Medical University
    • Yunnan
      • Kunming、Yunnan、中国
        • Department of Emergency Medicine and Medical ICU, The First Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou、Zhejiang、中国
        • Department of Critical Care Medicine, Zhejiang Provincial People's Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

All patients admitted to the participating ICUs during a 6-month period(from January 1, 2015 to July 1,2015 )

描述

Inclusion Criteria:

all patients age >18 yrs admitted to 24 participating ICUs

Exclusion Criteria:

No patients should be excluded (regardless of age, underlying disease, life expectancy, etc).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
ARDS, non-ARDS
patients with ARDS and patients without ARDS

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
incidence of acute respiratory distress syndrome (ARDS)
大体时间:from ICU admission to 28-day of ICU stay
incidence of ARDS = the number of patients developing ARDS during ICU / the total number of patients admitted to ICU
from ICU admission to 28-day of ICU stay

次要结果测量

结果测量
大体时间
ICU mortality of patients with ARDS
大体时间:followed up to 3 months after inclusion or to ICU discharge, whichever occurred first
followed up to 3 months after inclusion or to ICU discharge, whichever occurred first
hospital mortality of patients with ARDS
大体时间:followed up to 3 months after inclusion or to hospital discharge, whichever occurred first
followed up to 3 months after inclusion or to hospital discharge, whichever occurred first

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Bin Du、MICU of Peking Union Medical College Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年1月1日

初级完成 (实际的)

2015年8月1日

研究完成 (实际的)

2015年12月1日

研究注册日期

首次提交

2015年5月18日

首先提交符合 QC 标准的

2015年7月1日

首次发布 (估计)

2015年7月3日

研究记录更新

最后更新发布 (实际的)

2020年6月16日

上次提交的符合 QC 标准的更新

2020年6月13日

最后验证

2015年1月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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