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Clinical Trials/NCT02490215
NCT02490215CompletedNot Applicable

Epidemiology of Acute Respiratory Distress Syndrome in Chinese ICUs

Peking Union Medical College Hospital26 sites in 1 country2,530 target enrollmentStarted: January 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
2,530
Locations
26
Primary Endpoint
incidence of acute respiratory distress syndrome (ARDS)

Study Overview

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 .

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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).

Outcomes

Primary Outcomes

incidence of acute respiratory distress syndrome (ARDS)

Time Frame: 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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (26)

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