NCT02490215

Brief Summary

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,530

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 16, 2020

Status Verified

January 1, 2015

Enrollment Period

7 months

First QC Date

May 18, 2015

Last Update Submit

June 13, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • incidence of acute respiratory distress syndrome (ARDS)

    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

Secondary Outcomes (2)

  • ICU mortality of patients with ARDS

    followed up to 3 months after inclusion or to ICU discharge, whichever occurred first

  • hospital mortality of patients with ARDS

    followed up to 3 months after inclusion or to hospital discharge, whichever occurred first

Study Arms (1)

ARDS, non-ARDS

patients with ARDS and patients without ARDS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • all patients age \>18 yrs admitted to 24 participating ICUs

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

MICU, Peking union medical college hospital

Beijing, Beijing Municipality, 100730, China

Location

Beijing Hospital of ministry of Health

Beijing, Beijing Municipality, China

Location

Department of Critical Care Medicine, Fuxing Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

General ICU, Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

China-Japan Friendship Hospital

Beijng, Beijing Municipality, China

Location

Department of Emergency and Intensive Care Medicine, The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Location

Department of CriticalCare Medicine, Guangdong General Hospital

Guangzhou, Guangdong, China

Location

Department of Critical Care Medicine, Hainan Provincial People's Hospital

Haikou, Hainan, China

Location

Department of Critical Care Medicine, Hebei Medical University Fourth Hospital

Shijiazhuang, Hebei, China

Location

Department of Critical Care Medicine, The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

ICU, The First Affiliated Hospital, Zhengzhou University

Zhengzhou, Henan, China

Location

Department of Critical Care Medicine, Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei, China

Location

Department of Critical Care Medicine, Xiangya Hospital, Central South University

Changsha, Hunan, China

Location

Department of Critical Care Medicine, The Affiliated Hopsital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Location

Department of Critical Care Medicine, The Second Hospital of Jilin University

Changchun, Jilin, China

Location

Department of Critical Care Medicine, The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Location

Department of Critical Care Medicine, Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

Emergency ICU, Ruijin Hospital, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Location

Surgical Intensive Care Unit, Xijing Hospital

XiAn, Shanxi, China

Location

Department of Critical Care Medicine, West China Hospital, Sichuan University

Chengdu, Sichuan, China

Location

Department of Critical Care Medicine, First Affiliated Hospital, Xinjiang Medical University

Ürümqi, Xinjiang, China

Location

Department of Emergency Medicine and Medical ICU, The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

Department of Critical Care Medicine, Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Bin Du

    MICU of Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2015

First Posted

July 3, 2015

Study Start

January 1, 2015

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

June 16, 2020

Record last verified: 2015-01

Locations