NCT07289711 Validation and Precision Treatment of Inflammatory Subphenotypes in Acute Respiratory Distress Syndrome: A Multicenter Cohort Study
| NCT ID | NCT07289711 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Southeast University, China |
| Condition | Acute Respiratory Distress Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-12-29 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2025-12-29 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07289711 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Respiratory Distress Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07289711 currently recruiting?
Yes, NCT07289711 is actively recruiting participants. Contact the research team at huichen.icu@gmail.com for enrollment information.
Where is the NCT07289711 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07289711 clinical trial?
NCT07289711 is sponsored by Southeast University, China. The trial plans to enroll 500 participants.