Acute Respiratory Distress SyndromeCHARDSnetNCT02975908
A Realworld Study of Acute Respiratory Distress Syndrome in China
An observational study of Acute Respiratory Distress Syndrome, run by China-Japan Friendship Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥18 years of age; hospitalized patients with main diagnosis as ARDS.
Who cannot join
- <18 years of age
- Patients or their families refused to participate in the study
- Patients diagnosed as COPD, pulmonary fibrosis or bronchiectasis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China - Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Huang Xu, 8613641345816, huangxu1122@sina.com
Zhan Qingyuan, 8613911785957, dr.zhanqy@gmail.com
About this study
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.
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute Respiratory Distress Syndrome, epidemiology, clinical features, management, prognosis
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
the 28days mortality after the diagnosis of ARDS
Measured: 28days
Secondary outcomes (11)
Length of ICU stay
The days between admission to intensive care unit(ICU) and discharge from ICU.
Measured: 90 days
Ventilation free days
The days between successful weaning from mechanical ventilation and day 28 after study enrollment.
Measured: 28 days
Incidence of ARDS
The total number of acute respiratory distress syndrome(ARDS)patients in 2 years.
Measured: 2 years
Severity of patients
Number 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.
Measured: 2 years
Adverse events related to treatment
Number of patients with adverse events, include biotrauma, worsen of hemodynamics, hospital-acquired infection, patient-ventilator asynchrony, gastric distention, aspiration etc.
Measured: 90 days
Number of patients using adjuvant drugs
Adjuvant drugs refer to corticosteroid, sedative, analgesic and non depolarizing muscle relaxant.
Measured: 28 days
Number of patients with high risk factors
High 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.
Measured: 1 week
Number of patients with conventional respiratory support techniques
Conventional respiratory support techniques include noninvasive positive pressure ventilation(NPPV), invasive positive pressure ventilation(include volume-controlled ventilation and pressure-controlled ventilation) .
Measured: 28 days
Number of patients with unconventional respiratory support techniques
Unconventional 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)
Measured: 28 days
Number of patients with impaired lung function
The number patients with impaired lung function 90 days and 1 year after diagnosis of acute respiratory distress syndrome(ARDS).
Measured: 90 days, 1 year
Number of patients with abnormal lung CT
The number patients with abnormal lung CT 90 days and 1 year after diagnosis of acute respiratory distress syndrome(ARDS).
Measured: 90 days, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startAug 2015
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- PLA General Hospital, Second Xiangya Hospital of Central South University, Xiangya Hospital of Central South University, The Second Affiliated Hospital of Chongqing Medical University, Beijing Chao Yang Hospital, First Affiliated Hospital of Xinjiang Medical University, First Hospital of China Medical University, Nanjing General Hospital, Peking University First Hospital, Third Hospital Affiliated to Neimenggu Medical University, The Second Hospital of Hebei Medical University, Qilu Hospital of Shandong University, Ruijin Hospital, Beijing Hospital, Peking Union Medical College Hospital, No.3 Hospital of Peking University, Fuxing Hospital, Fujian Provincial Hospital
- Responsible party
- Principal investigator, Chen Wang, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975908
- Sponsor's protocol ID
- CHARDS20160301
- Acronym
- CHARDSnet
- Status last verified
- Nov 2016
- First submitted
- 5 Apr 2016
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Yang H, Xia J, Huang X, Bai Y, Jin D, Nouraie SM, McVerry BJ, Morris A, Kitsios GD, Wang C, Zhan Q. Generalisability of ARDS biological subphenotype models in Asians: an international, multicentre, prospective biomarker study. Thorax. 2026 Feb 16;81(3):257-266. doi: 10.1136/thorax-2025-223421.
PubMed 41167619Huang 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.
PubMed 32819400
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Realworld Study of Acute Respiratory Distress Syndrome in China
- ClinicalTrials.gov ID
- NCT02975908
- Acronym / sponsor ID
- CHARDSnet / CHARDS20160301
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute Respiratory Distress Syndrome, epidemiology, clinical features, management, prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Collaborators
- PLA General Hospital, Second Xiangya Hospital of Central South University, Xiangya Hospital of Central South University, The Second Affiliated Hospital of Chongqing Medical University, Beijing Chao Yang Hospital, First Affiliated Hospital of Xinjiang Medical University, First Hospital of China Medical University, Nanjing General Hospital, Peking University First Hospital, Third Hospital Affiliated to Neimenggu Medical University, The Second Hospital of Hebei Medical University, Qilu Hospital of Shandong University, Ruijin Hospital, Beijing Hospital, Peking Union Medical College Hospital, No.3 Hospital of Peking University, Fuxing Hospital, Fujian Provincial Hospital
- Study start
- Aug 2015
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- ≥18 years of age; hospitalized patients with main diagnosis as ARDS.
Key exclusion criteria (3 listed)
- <18 years of age
- Patients or their families refused to participate in the study
- Patients diagnosed as COPD, pulmonary fibrosis or bronchiectasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 28days
the 28days mortality after the diagnosis of ARDS
11 secondary outcomes
Length of ICU stay
Time frame: 90 days
Ventilation free days
Time frame: 28 days
Incidence of ARDS
Time frame: 2 years
Severity of patients
Time frame: 2 years
Adverse events related to treatment
Time frame: 90 days
Number of patients using adjuvant drugs
Time frame: 28 days
Number of patients with high risk factors
Time frame: 1 week
Number of patients with conventional respiratory support techniques
Time frame: 28 days
Number of patients with unconventional respiratory support techniques
Time frame: 28 days
Number of patients with impaired lung function
Time frame: 90 days, 1 year
Number of patients with abnormal lung CT
Time frame: 90 days, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- Derived from this study: PubMed 41167619Yang H, Xia J, Huang X, Bai Y, Jin D, Nouraie SM, McVerry BJ, Morris A, Kitsios GD, Wang C, Zhan Q. Generalisability of ARDS biological subphenotype models in Asians: an international, multicentre, prospective biomarker study. Thorax. 2026 Feb 16;81(3):257-266. doi: 10.1136/thorax-2025-223421.
- Derived from this study: PubMed 32819400Huang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huang Xu (8613641345816, huangxu1122@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 28days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02975908, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2016.