Epidemiology of Acute Respiratory Distress Syndrome in Chinese ICUs

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Epidemiology of Acute Respiratory Distress Syndrome in Chinese ICUs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02490215
• Other study ID #: MICU2015_1
• Status: Completed
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2015
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2530
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ICU mortality of patients with ARDS		followed up to 3 months after inclusion or to ICU discharge, whichever occurred first
Secondary	hospital mortality of patients with ARDS		followed up to 3 months after inclusion or to hospital discharge, whichever occurred first