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临床试验/NCT07289711
NCT07289711招募中不适用

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

Southeast University, China1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年12月29日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
28-day mortality

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years.
  • ARDS with new Global definition.
  • Onset of ARDS within 72 hours.

排除标准

  • 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

研究组 & 干预措施

ARDS patients with hyperinflammatory phenotype

ARDS patients with hyperinflammatory phenotype

干预措施: ARDS Inflammatory Subphenotypes (Other)

结局指标

主要结局

28-day mortality

时间窗: From inclusion to 28 days

The proportion of patients who are died within 28 days

次要结局

  • 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)

研究者

发起方
Southeast University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ling Liu

Professor

Southeast University, China

研究点 (1)

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