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A Realworld Study of Acute Respiratory Distress Syndrome in China

A Realworld Study of Acute Respiratory Distress Syndrome in China

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02975908
Acronym
CHARDSnet
Enrollment
400
Registered
2016-11-29
Start date
2015-08-31
Completion date
2019-02-28
Last updated
2016-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute Respiratory Distress Syndrome, epidemiology, clinical features, management, prognosis

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.

Interventions

None listed

Sponsors

PLA General Hospital
CollaboratorUNKNOWN
Second Xiangya Hospital of Central South University
CollaboratorOTHER
Xiangya No.1 Hospital of Central South University
CollaboratorUNKNOWN
The Second Affiliated Hospital of Chongqing Medical University
CollaboratorOTHER
Beijing Chao Yang Hospital
CollaboratorOTHER
First Affiliated Hospital of Xinjiang Medical University
CollaboratorOTHER
First Hospital Affiliated to China Medical University
CollaboratorUNKNOWN
Nanjing General Hospital
CollaboratorUNKNOWN
Peking University First Hospital
CollaboratorOTHER
Third Hospital Affiliated to Neimenggu Medical University
CollaboratorUNKNOWN
Second Hospital Affiliated to Hebei Medical University
CollaboratorUNKNOWN
Qilu Hospital of Shandong University
CollaboratorOTHER
First Hospital Affiliated to Anhui Medical University
CollaboratorUNKNOWN
Ruijin Hospital
CollaboratorOTHER
Beijing Hospital
CollaboratorOTHER_GOV
Peking Union Medical College Hospital
CollaboratorOTHER
No.3 Hospital of Peking University
CollaboratorUNKNOWN
Fuxing Hospital
CollaboratorUNKNOWN
Fujian Provincial Hospital
CollaboratorOTHER
China-Japan Friendship Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mortality28daysthe 28days mortality after the diagnosis of ARDS

Secondary

MeasureTime frameDescription
Ventilation free days28 daysThe days between successful weaning from mechanical ventilation and day 28 after study enrollment.
Incidence of ARDS2 yearsThe total number of acute respiratory distress syndrome(ARDS)patients in 2 years.
Severity of patients2 yearsNumber of patients in each grade of severities according to Berlin definition: the number of mild, moderate and severe acute respiratory distress syndrome(ARDS) patients will be recorded.
Adverse events related to treatment90 daysNumber of patients with adverse events, include biotrauma, worsen of hemodynamics, hospital-acquired infection, patient-ventilator asynchrony, gastric distention, aspiration etc.
Number of patients using adjuvant drugs28 daysAdjuvant drugs refer to corticosteroid, sedative, analgesic and non depolarizing muscle relaxant.
Length of ICU stay90 daysThe days between admission to intensive care unit(ICU) and discharge from ICU.
Number of patients with conventional respiratory support techniques28 daysConventional respiratory support techniques include noninvasive positive pressure ventilation(NPPV), invasive positive pressure ventilation(include volume-controlled ventilation and pressure-controlled ventilation) .
Number of patients with unconventional respiratory support techniques28 daysUnconventional respiratory support techniques include recruitment maneuver(RM), prone position ventilation(PPV), high-frequency oscillatory ventilation(HFOV) ,extracorporeal membrane oxygenation(ECMO) and extracorporeal CO2 removal(ECCO2R)
Number of patients with impaired lung function90 days, 1 yearThe number patients with impaired lung function 90 days and 1 year after diagnosis of acute respiratory distress syndrome(ARDS).
Number of patients with abnormal lung CT90 days, 1 yearThe number patients with abnormal lung CT 90 days and 1 year after diagnosis of acute respiratory distress syndrome(ARDS).
Number of patients with high risk factors1 weekHigh risk factors for acute respiratory distress syndrome(ARDS), including endogenous factors as pneumonia, aspiration, lung contusion and drowning; the exogenous factors as extrapulmonary trauma, extra pulmonary sepsis , hypovolemic shock, pancreatitis, severe burning, drug overdose, blood transfusion,eclampsia etc.

Countries

China

Contacts

Primary ContactHuang Xu
huangxu1122@sina.com8613641345816
Backup ContactZhan Qingyuan
dr.zhanqy@gmail.com8613911785957

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026