NCT02975908

Brief Summary

ARDS is a critical respiratory disease caused by endogenous and exogenous factors. The mortality of ARDS varies from 30 to 70%. In 2012, a new international diagnostic criterion has been put forward. Yet, its feasibility, reliability and validity need to be tested. Meanwhile, the correlation of different severity and prognosis remains unclear. As so far, the epidemiological information about ARDS in China is lacking. Investigators plan to conduct a multi-center observational study(real-life study) to investigate the risk factors, morbidity, management and prognosis of ARDS in China, in order to facilitate standardization of diagnosis and management of ARDS and provide basic data and idea for further clinical intervention studies.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2016

Completed
8 months until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

2.5 years

First QC Date

April 5, 2016

Last Update Submit

November 23, 2016

Conditions

Keywords

Acute Respiratory Distress Syndromeepidemiologyclinical featuresmanagementprognosis

Outcome Measures

Primary Outcomes (1)

  • Mortality

    the 28days mortality after the diagnosis of ARDS

    28days

Secondary Outcomes (11)

  • Length of ICU stay

    90 days

  • Ventilation free days

    28 days

  • Incidence of ARDS

    2 years

  • Severity of patients

    2 years

  • Adverse events related to treatment

    90 days

  • +6 more secondary outcomes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This research plans to enroll 400 hospitalized patients (≥ 18 years old with main diagnosis as ARDS). Sample size estimation is based on estimated mortality of ARDS hospitalized patients (\~5%). Study patients will be recruited from 20 hospitals across China,each hospital will recruit 20 patients. Hospital selection follows a multi-stage sampling strategy.

You may qualify if:

  • ≥18 years of age; hospitalized patients with main diagnosis as ARDS.

You may not qualify if:

  • \<18 years of age
  • Patients or their families refused to participate in the study
  • Patients diagnosed as COPD, pulmonary fibrosis or bronchiectasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China - Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Related Publications (2)

  • Yang H, Xia J, Huang X, Bai Y, Jin D, Nouraie SM, McVerry BJ, Morris A, Kitsios GD, Wang C, Zhan Q. Generalisability of ARDS biological subphenotype models in Asians: an international, multicentre, prospective biomarker study. Thorax. 2025 Oct 29:thorax-2025-223421. doi: 10.1136/thorax-2025-223421. Online ahead of print.

  • Huang X, Zhang R, Fan G, Wu D, Lu H, Wang D, Deng W, Sun T, Xing L, Liu S, Wang S, Cai Y, Tian Y, Zhang Y, Xia J, Zhan Q; CHARDSnet group. Incidence and outcomes of acute respiratory distress syndrome in intensive care units of mainland China: a multicentre prospective longitudinal study. Crit Care. 2020 Aug 20;24(1):515. doi: 10.1186/s13054-020-03112-0.

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 5, 2016

First Posted

November 29, 2016

Study Start

August 1, 2015

Primary Completion

February 1, 2018

Study Completion

February 1, 2019

Last Updated

November 29, 2016

Record last verified: 2016-11

Locations