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Clinical Trials/NCT07289711
NCT07289711
Recruiting
Not Applicable

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

Southeast University, China1 site in 1 country500 target enrollmentStarted: December 29, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Southeast University, China
Enrollment
500
Locations
1
Primary Endpoint
28-day mortality

Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥ 18 years.
  • ARDS requiring invasive mechanical ventilation, diagnosed according to the 2023 Global definition.
  • Onset of ARDS within 72 hours.

Exclusion Criteria

  • Refusal of informed consent by the patient's legally authorized representative.
  • Patients expected to die within 24 hours

Outcomes

Primary Outcomes

28-day mortality

Time Frame: From inclusion to 28 days

The proportion of patients who are died within 28 days

Secondary Outcomes

  • Ventilator-free days at 28 days(From inclusion to 28 days)
  • 60-day mortality(From inclusion to 60 days)
  • Vasopressor-free days at 28 days(From inclusion to 28 days)

Investigators

Sponsor
Southeast University, China
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ling Liu

Professor

Southeast University, China

Study Sites (1)

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