Using inflammatory subtypes to personalize treatment for adults with ARDS
Official title: Validation and Precision Treatment of Inflammatory Subphenotypes in Acute Respiratory Distress Syndrome: A Multicenter Cohort Study
Run by Southeast University, China · NCT07289711 · Data updated 2026-11-12
This project will test whether dividing adults with ARDS on ventilators into 'hyperinflammatory' and 'hypoinflammatory' groups works in Chinese hospitals and can help guide care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Southeast University, China Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | December 29, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 13, 2026 |
| Trial ID | NCT07289711 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) with ARDS requiring invasive mechanical ventilation within 72 hours of onset who have consent from a legally authorized representative are eligible.
✕Probably not a fit
Patients expected to die within 24 hours or those unable/unwilling to provide required samples may not receive direct benefit from the classification.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational multicenter cohort approach enrolling adults with ARDS who require invasive mechanical ventilation within 72 hours of onset. Researchers will collect clinical data and blood biomarkers to classify patients into previously described inflammatory subphenotypes and apply statistical models to validate those classifications in this population. The study will compare organ dysfunction patterns, clinical trajectories, and real-world treatment responses between subphenotypes without altering standard care. Results will examine whether the inflammatory categories seen in prior trials reproduce in a Chinese ICU cohort and correlate with outcomes.
Why it matters
Potential benefit: If successful, this could help clinicians tailor treatments by inflammatory subtype and potentially improve outcomes for some ARDS patients.
How similar studies have gone: Earlier analyses of randomized trials have reproducibly identified hyperinflammatory and hypoinflammatory ARDS subphenotypes with different clinical courses and treatment responses, though validation in Chinese populations is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years. 2. ARDS with new Global definition. 3. Onset of ARDS within 72 hours. Exclusion Criteria: 1. Refusal of informed consent by the patient's legally authorized representative. 2. Patients expected to die within 24 hours 3. Receiving extracorporeal membrane oxygenation at the time of recruitment
Where it's running
-
Zhongda Hospital, School of Medicine, Southeast University
Nanjing, Jiangsu, China Recruiting
Study contacts
- Study coordinator: Hui Chen, MD
- Email: huichen.icu@gmail.com
- Phone: +8618006138640
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.