Validation and Precision Treatment of Inflammatory Subphenotypes in Acute Respiratory Distress Syndrome: A Multicenter Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ARDS Inflammatory Subphenotypes.
- Who it may be relevant to
- Registry conditions: Acute Respiratory Distress Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other ARDS Inflammatory Subphenotypes
ARDS patients with idfferent Inflammatory Subphenotypes
Primary outcome measures
- 28-day mortality [Time frame: From inclusion to 28 days]
Secondary outcome measures (3)
- 60-day mortality [Time frame: From inclusion to 60 days]
- Ventilator-free days at 28 days [Time frame: From inclusion to 28 days]
- Vasopressor-free days at 28 days [Time frame: From inclusion to 28 days]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years.
- ARDS with new 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
- Receiving extracorporeal membrane oxygenation at the time of recruitment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Zhongda Hospital, School of Medicine, Southeast University — Nanjing
Identifiers
NCT: NCT07289711 · Subphenotype Of ARDS