Explore Potential Plasma and BALF Immunometabolic and Lipidomic Biomarkers for Identifying the Endotypes in Patients With ARDS
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Identification of ARDS Endotypes
研究概览
简要总结
Acute respiratory distress syndrome (ARDS) is a life-threatening condition that causes high mortality (41% to 58%). Previous studies have reported that biomarkers can facilitate phenotypic diagnosis of ARDS, enabling precision treatment of ARDS. Although there were many studies that found some potential therapeutic targets for ARDS, no pharmacotherapies have been validated to treat ARDS. The development of biomarkers to predict the prognosis and monitor the response to treatment would be of interest for selecting patients for specific therapeutic trials. Many recent studies have shown that immune metabolic changes are involved in the pathogenesis of ARDS and may become a new therapeutic target for them. We aimed to identify a panel of immunometabolic and lipidomic biomarkers derived from blood and bronchoalveolar lavage fluid (BALF) which may help differentiate the ARDS endotypes.
详细描述
PROTOCOL OUTLINE:
This is an observational study. The blood and BALF samples will be collected from patients with ARDS for exosome extraction and transcriptome and metabolomic analysis.
Exosome characterization and differential genes and metabolites will be identified.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 否
入选标准
- •Aged >18 years old;
- •Meet the diagnostic criteria of ARDS according to the Berlin Criteria.
排除标准
- •Aged≤18 years old;
- •No informed consent;
结局指标
主要结局
Identification of ARDS Endotypes
时间窗: 2 years
Blood samples will be collected on day 1, 3, 5,7 since ARDS diagnosis is made (day 0) and BALF samples will be collected on day 1 and day 7. Blood samples are used to extract PBMC and BALF samples are used to extract alveolar macrophage. Afterwards, PBMC and alveolar macrophage are saved for further transcriptomic and metabomic analysis. At the same time, clinical and biological date are collected to identify subgroups of patients that might share mortality risk, clinical course, and/or treatment responsiveness. At last, the relationship between transcriptomic and metabomic signature of PBMC and alveolar macrophage and the clinical phenotypes are analyzed to determine ARDS endotypes.
次要结局
- Correlation of Endotypes with published ARDS specific Biomarkers(2 years)
- Correlation of Endotypes with Intensive care unit-free days(Until 28 days following ICU admission)
- Correlation of Endotypes with Ventilator-free days(Until 28 days following ICU admission)
- Correlation of Endotypes with All-cause mortality(Until death or hospital discharge, assessed up to 28 days following ICU admission)
- Compare the PBMC and alveolar macrophage derived exosome levels between patients with ARDS and without ARDS(2 years)