ARDS (Acute Respiratory Distress Syndrome)NCT07165717
A Real World Study of Respiratory Critical Disease.
An observational study of ARDS (Acute Respiratory Distress Syndrome) and Real World Study, run by Ming Zhong at 1 site in China.
Trial summary
Acute Respiratory Distress Syndrome (ARDS) is a form of acute diffuse lung injury caused by various etiologies, which rapidly progresses to acute respiratory failure. It is characterized by a sudden onset and severe clinical course. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome), Real World Study
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients identified as high risk for ARDS after ICU admission.
Who may be able to join
- Patients with underlying diseases associated with high risk of ARDS, including but not limited to: sepsis, pneumonia, multiple trauma, pulmonary contusion, inhalation injury, massive blood transfusion, other high-risk conditions, or other factors causing excessive respiratory drive.
- Patients meeting the inclusion criteria for a high-risk ARDS population.
- Patients (or legal representatives) who have provided a signed and dated informed consent form.
Who cannot join
- Age under 18 years.
- HIV infection.
- Known immunodeficiency disorders (e.g., leukemia, common variable immunodeficiency, etc.).
- History of solid organ or bone marrow transplantation.
- Receiving treatment with G-CSF or GM-CSF.
- Patients with a decision to withdraw from active treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University, Zhong Shan Hospital
Shanghai, Shanghai Municipality, 200032
About this study
Acute Respiratory Distress Syndrome (ARDS) is a form of acute diffuse lung injury caused by various etiologies, which rapidly progresses to acute respiratory failure. It is characterized by a sudden onset and severe clinical course. Globally, ARDS affects approximately 3 million individuals each year, accounting for about 10% of admissions to intensive care units (ICUs). Due to the lack of specific pharmacological therapies, mechanical ventilation remains the mainstay of treatment. Therefore, identifying and analyzing prognostic factors for ARDS patients is of great significance for improving patient outcomes and reducing the incidence of poor prognosis.
- Being tested
- No Intervention: Observational Cohort
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
Obsercational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Clinical observation
Measured: Day 28 after ARDS diagnosis
Mortality
Clinical observation
Measured: Day 60 after ARDS diagnosis
Secondary outcomes (5)
Chest CT Scan
Chest CT imaging
Measured: Monitored daily
Complete Blood Count
Blood sampling and laboratory testing
Measured: Monitored daily
Serial Arterial Blood Gas Monitoring
Arterial blood gas collection
Measured: Monitored daily after enrollment
Fluid Input and Output Balance
Clinical nursing records
Measured: Whenever fluid input or output occurs
Mechanical Ventilation Monitoring
Automatically recorded by ventilator
Measured: Every second after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Mar 2019
- Primary completion31 Jul 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Acute Respiratory Distress Syndrome)Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ming Zhong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ming Zhong, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165717
- Sponsor's protocol ID
- B2023-016
- Status last verified
- Sep 2025
- First submitted
- 13 Jun 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Study of Respiratory Critical Disease.
- ClinicalTrials.gov ID
- NCT07165717
- Acronym / sponsor ID
- B2023-016
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ming ZhongUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Sep 2025 (actual)
- 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.
Acute Respiratory Distress Syndrome (ARDS) is a form of acute diffuse lung injury caused by various etiologies, which rapidly progresses to acute respiratory failure. It is characterized by a sudden onset and severe clinical course. Globally, ARDS affects approximately 3 million individuals each year, accounting for about 10% of admissions to intensive care units (ICUs). Due to the lack of specific pharmacological therapies, mechanical ventilation remains the mainstay of treatment. Therefore, identifying and analyzing prognostic factors for ARDS patients is of great significance for improving patient outcomes and reducing the incidence of poor prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients identified as high risk for ARDS after ICU admission.
Key inclusion criteria (3 listed)
- Patients with underlying diseases associated with high risk of ARDS, including but not limited to: sepsis, pneumonia, multiple trauma, pulmonary contusion, inhalation injury, massive blood transfusion, other high-risk conditions, or other factors causing excessive respiratory drive.
- Patients meeting the inclusion criteria for a high-risk ARDS population.
- Patients (or legal representatives) who have provided a signed and dated informed consent form.
Key exclusion criteria (6 listed)
- Age under 18 years.
- HIV infection.
- Known immunodeficiency disorders (e.g., leukemia, common variable immunodeficiency, etc.).
- History of solid organ or bone marrow transplantation.
- Receiving treatment with G-CSF or GM-CSF.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortObsercational study | Other | – |
Primary outcome
Mortality
Time frame: Day 28 after ARDS diagnosis
Clinical observation
Mortality
Time frame: Day 60 after ARDS diagnosis
Clinical observation
5 secondary outcomes
Chest CT Scan
Time frame: Monitored daily
Complete Blood Count
Time frame: Monitored daily
Serial Arterial Blood Gas Monitoring
Time frame: Monitored daily after enrollment
Fluid Input and Output Balance
Time frame: Whenever fluid input or output occurs
Mechanical Ventilation Monitoring
Time frame: Every second after intubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: Yes
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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.
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 ARDS (Acute Respiratory Distress Syndrome) and Real World Study, run by Ming Zhong 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuxian Wang, Doctor (86-13482359545, wang.yuxian@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Day 28 after ARDS diagnosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2025.