Acute Respiratory Distress Syndrome
Conditions
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.
Interventions
OTHERARDS Inflammatory Subphenotypes
ARDS patients with idfferent Inflammatory Subphenotypes
Sponsors
Southeast University, China
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-day mortality | From inclusion to 28 days | The proportion of patients who are died within 28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 60-day mortality | From inclusion to 60 days | The proportion of patients who are died within 60 days |
| Ventilator-free days at 28 days | From inclusion to 28 days | Days alive without endotracheal intubation and invasive mechanical ventilation |
| Vasopressor-free days at 28 days | From inclusion to 28 days | Days alive without use of vasopressor |
Countries
China
Contacts
CONTACTHui Chen, MD
Outcome results
None listed