Clinical trial NCT02975908: A Realworld Study of Acute Respiratory Distress Syndrome in China
Official title: A Realworld Study of Acute Respiratory Distress Syndrome in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Respiratory Distress Syndrome
Keywords: Acute Respiratory Distress Syndrome
epidemiology
clinical features
management
prognosis
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
Collaborators: name: PLA General Hospital
name: Xiangya No.2 Hospital of Central South University
name: Xiangya No.1 Hospital of Central South University
name: The Second Affiliated Hospital of Chongqing Medical University
name: Beijing Chao Yang Hospital
name: First Affiliated Hospital of Xinjiang Medical University
name: First Hospital Affiliated to China Medical University
name: Nanjing General Hospital
name: Peking University First Hospital
name: Third Hospital Affiliated to Neimenggu Medical University
name: Second Hospital Affiliated to Hebei Medical University
name: Qilu Hospital of Shandong University
name: First Hospital Affiliated to Anhui Medical University
name: Ruijin Hospital
name: Beijing Hospital
name: Peking Union Medical College Hospital
name: No.3 Hospital of Peking University
name: Fuxing Hospital
name: Fujian Provincial Hospital
First posted: 2016-11-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Mortality
timeFrame: 28days
Secondary outcomes:
measure: Length of ICU stay
timeFrame: 90 days
measure: Ventilation free days
timeFrame: 28 days
measure: Incidence of ARDS
timeFrame: 2 years
measure: Severity of patients
timeFrame: 2 years
measure: Adverse events related to treatment
timeFrame: 90 days
measure: Number of patients using adjuvant drugs
timeFrame: 28 days
measure: Number of patients with high risk factors
timeFrame: 1 week
measure: Number of patients with conventional respiratory support techniques
timeFrame: 28 days
measure: Number of patients with unconventional respiratory support techniques
timeFrame: 28 days
measure: Number of patients with impaired lung function
timeFrame: 90 days, 1 year
measure: Number of patients with abnormal lung CT
timeFrame: 90 days, 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: China - Japan Friendship Hospital
state: Beijing
Study officials:
References:
citation: 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.