Acute Respiratory Distress SyndromeVATICNCT07289711
Validation and Precision Treatment of Inflammatory Subphenotypes in Acute Respiratory Distress Syndrome: A Multicenter Cohort Study
An observational study of Acute Respiratory Distress Syndrome, run by Southeast University, China at 1 site in China.
Trial summary
Acute respiratory distress syndrome (ARDS) is a common and life-threatening condition in intensive care units, characterized by substantial biological and clinical heterogeneity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- ARDS Inflammatory Subphenotypes
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 29 Dec 2025to 31 Dec 2026
- 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 with ARDS
Who may be able to join
- Age ≥ 18 years.
- ARDS with new Global definition.
- Onset of ARDS within 72 hours.
Who cannot join
- Refusal of informed consent by the patient's legally authorized representative.
- Patients expected to die within 24 hours
- Receiving extracorporeal membrane oxygenation at the time of recruitment
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
Zhongda Hospital, School of Medicine, Southeast University
Nanjing, Jiangsu, 210009
Hui Chen, +86-18006138640, 15905162429@163.com
About this study
Acute respiratory distress syndrome (ARDS) is a common and life-threatening condition in intensive care units, characterized by substantial biological and clinical heterogeneity. Differences in patients' inflammatory responses, baseline immune function, and organ failure patterns contribute to variability in ARDS severity, treatment response, and clinical outcomes. Precision classification of ARDS based on biological and inflammatory characteristics may therefore be essential for improving patient outcomes. Previous analyses of randomized clinical trials have identified two reproducible inflammatory subphenotypes-"hyperinflammatory" and "hypoinflammatory"-which differ in organ dysfunction profiles, clinical trajectories, and responses to treatments such as fluid management strategies, corticosteroids, and ventilatory interventions. However, key uncertainties remain, including whether these inflammatory subphenotypes can be validated in Chinese ARDS populations, how various bedside prediction models perform in identifying these subphenotypes, and whether model-based subphenotype identification can guide individualized treatment decisions. This multicenter cohort study aims to: (1) validate inflammatory subphenotypes of ARDS using latent class analysis; (2) compare the predictive performance of existing bedside models for subphenotype identification; and (3) assess whether subphenotype assignment based on prediction models can guide individualized treatment strategies, including fluid management, PEEP titration, and corticosteroid use. In addition to these primary aims, the study may include other exploratory objectives, such as evaluating subphenotype stability over time, characterizing biological pathways associated with subphenotypes, and assessing additional treatment-response patterns to support future precision ARDS management strategies.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- ARDS Inflammatory Subphenotypes
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARDS Inflammatory SubphenotypesOther
ARDS patients with idfferent Inflammatory Subphenotypes
| Study group | Role | What they receive |
|---|---|---|
| ARDS patients with hyperinflammatory phenotype | ARDS patients with hyperinflammatory phenotype Receives: Other: ARDS Inflammatory Subphenotypes |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
The proportion of patients who are died within 28 days
Measured: From inclusion to 28 days
Secondary outcomes (3)
60-day mortality
The proportion of patients who are died within 60 days
Measured: From inclusion to 60 days
Ventilator-free days at 28 days
Days alive without endotracheal intubation and invasive mechanical ventilation
Measured: From inclusion to 28 days
Vasopressor-free days at 28 days
Days alive without use of vasopressor
Measured: From inclusion to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start29 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289711
- Sponsor's protocol ID
- Subphenotype Of ARDS
- Acronym
- VATIC
- Status last verified
- Jul 2026
- First submitted
- 4 Dec 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Precision Treatment of Inflammatory Subphenotypes in Acute Respiratory Distress Syndrome: A Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT07289711
- Acronym / sponsor ID
- VATIC / Subphenotype Of ARDS
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Dec 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 common and life-threatening condition in intensive care units, characterized by substantial biological and clinical heterogeneity. Differences in patients' inflammatory responses, baseline immune function, and organ failure patterns contribute to variability in ARDS severity, treatment response, and clinical outcomes. Precision classification of ARDS based on biological and inflammatory characteristics may therefore be essential for improving patient outcomes. Previous analyses of randomized clinical trials have identified two reproducible inflammatory subphenotypes-"hyperinflammatory" and "hypoinflammatory"-which differ in organ dysfunction profiles, clinical trajectories, and responses to treatments such as fluid management strategies, corticosteroids, and ventilatory interventions. However, key uncertainties remain, including whether these inflammatory subphenotypes can be validated in Chinese ARDS populations, how various bedside prediction models perform in identifying these subphenotypes, and whether model-based subphenotype identification can guide individualized treatment decisions. This multicenter cohort study aims to: (1) validate inflammatory subphenotypes of ARDS using latent class analysis; (2) compare the predictive performance of existing bedside models for subphenotype identification; and (3) assess whether subphenotype assignment based on prediction models can guide individualized treatment strategies, including fluid management, PEEP titration, and corticosteroid use. In addition to these primary aims, the study may include other exploratory objectives, such as evaluating subphenotype stability over time, characterizing biological pathways associated with subphenotypes, and assessing additional treatment-response patterns to support future precision ARDS management strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARDS patients with hyperinflammatory phenotype | – | Other: ARDS Inflammatory SubphenotypesARDS patients with hyperinflammatory phenotype |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ARDS
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- ARDS with new Global definition.
- Onset of ARDS within 72 hours.
Key exclusion criteria (3 listed)
- Refusal of informed consent by the patient's legally authorized representative.
- Patients expected to die within 24 hours
- Receiving extracorporeal membrane oxygenation at the time of recruitment
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 |
|---|---|---|
| ARDS Inflammatory SubphenotypesARDS patients with idfferent Inflammatory Subphenotypes | Other | ARDS patients with hyperinflammatory phenotype |
Primary outcome
28-day mortality
Time frame: From inclusion to 28 days
The proportion of patients who are died within 28 days
3 secondary outcomes
60-day mortality
Time frame: From inclusion to 60 days
Ventilator-free days at 28 days
Time frame: From inclusion to 28 days
Vasopressor-free days at 28 days
Time frame: From inclusion to 28 days
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 13 Jul 2026.
- Individual participant dataSharing planned: No
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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 Acute Respiratory Distress Syndrome, run by Southeast University, China 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 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. 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 Hui Chen, MD (+8618006138640, huichen.icu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: From inclusion to 28 days). 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 13 Jul 2026.