Using inflammatory subtypes to personalize treatment for adults with ARDS

Validation and Precision Treatment of Inflammatory Subphenotypes in Acute Respiratory Distress Syndrome: A Multicenter Cohort Study

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
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Southeast University, China (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07289711 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years.
2. ARDS requiring invasive mechanical ventilation, diagnosed according to the 2023 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

Where this trial is running

Nanjing, Jiangsu

• Zhongda Hospital, School of Medicine, Southeast University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Hui Chen, MD

Conditions Acute Respiratory Distress Syndrome