Clinical trial NCT02490215: Epidemiology of Acute Respiratory Distress Syndrome in Chinese ICUs
Official title: Epidemiology of Acute Respiratory Distress Syndrome in Chinese ICUs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2015-07-03
Enrollment: 2530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to the participating ICUs during a 6-month period(from January 1, 2015 to July 1,2015 )

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.

Eligibility criteria: 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).

Primary outcomes:
measure: incidence of acute respiratory distress syndrome (ARDS)
timeFrame: from ICU admission to 28-day of ICU stay
Secondary outcomes:
measure: ICU mortality of patients with ARDS
timeFrame: followed up to 3 months after inclusion or to ICU discharge, whichever occurred first
measure: hospital mortality of patients with ARDS
timeFrame: followed up to 3 months after inclusion or to hospital discharge, whichever occurred first
Other outcomes:
Locations:
city: Beijing
country: China
facility: MICU, Peking union medical college hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital of ministry of Health
state: Beijing
city: Beijing
country: China
facility: Department of Critical Care Medicine, Fuxing Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: General ICU, Beijing Tongren Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijng
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: ChongQing
country: China
facility: Department of Emergency and Intensive Care Medicine, The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: Department of CriticalCare Medicine, Guangdong General Hospital
state: Guangdong
city: HaiKou
country: China
facility: Department of Critical Care Medicine, Hainan Provincial People's Hospital
state: Hainan
city: Shijiazhuang
country: China
facility: Department of Critical Care Medicine, Hebei Medical University Fourth Hospital
state: Hebei
city: Harbin
country: China
facility: Department of Critical Care Medicine, The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: ICU, The First Affiliated Hospital, Zhengzhou University
state: Henan
city: WuHan
country: China
facility: Department of Critical Care Medicine, Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology
state: Hubei
city: Changsha
country: China
facility: Department of Critical Care Medicine, Xiangya Hospital, Central South University
state: Hunan
city: Hohhot
country: China
facility: Department of Critical Care Medicine, The Affiliated Hopsital of Inner Mongolia Medical University
state: Inner Mongolia
city: ChangChun
country: China
facility: Department of Critical Care Medicine, The Second Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Department of Critical Care Medicine, The First Affiliated Hospital of China Medical University
state: Liaoning
city: YinChuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Jinan
country: China
facility: Department of Critical Care Medicine, Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Emergency ICU, Ruijin Hospital, Shanghai Jiao Tong University
state: Shanghai
city: XiAn
country: China
facility: Surgical Intensive Care Unit, Xijing Hospital
state: Shanxi
city: Chengdu
country: China
facility: Department of Critical Care Medicine, West China Hospital, Sichuan University
state: Sichuan
city: Urumqi
country: China
facility: Department of Critical Care Medicine, First Affiliated Hospital, Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: Department of Emergency Medicine and Medical ICU, The First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: Department of Critical Care Medicine, Zhejiang Provincial People's Hospital
state: Zhejiang
Study officials:
affiliation: MICU of Peking Union Medical College Hospital
name: Bin Du
role: PRINCIPAL_INVESTIGATOR
References: