NCT07675265招募中不适用
Observational Biomarker Study for the Evaluation of Response and Validation of Endotypes in Acute Respiratory Distress Syndrome
Prenosis, Inc.1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2026年9月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Number of Participants with an ARDS Diagnosis
研究概览
简要总结
The goal of this observational study is to establish a centralized ARDS biorepository of longitudinal biospecimens and harmonized clinical data, develop unsupervised, therapy-agnostic endotyping algorithms, and develop unsupervised, therapy-specific treatment-prediction algorithms over a 24 month period.
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 前瞻性
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
- Age ≥18 years
- ARDS Diagnosis (New Global Definition of ARDS)
- Timing: Acute onset within 7 days
- Radiology: Bilateral pulmonary opacities
- Hypoxia:
- Non-intubated ARDS: PaO2:FIO2<300mmHg or SpO2:FIO2<315 (if SpO2<97%) on HFNO with flow of >30 L/min or NIV/CPAP with at least 5 cm H2O end-expiratory pressure; or Intubated ARDS: PaO2:FIO2<300 mm Hg or SpO2:FIO2<315 (if SpO2<97%)
- ICU admission
- Enrolled within 72 hours of meeting inclusion criteria
排除标准
- Primary cardiogenic pulmonary edema
结局指标
主要结局
Number of Participants with an ARDS Diagnosis
时间窗: from enrollment to 28-day in-hospital mortality
Adults with clinically defined ARDS receiving ICU-level care
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
标识符
- NCT 编号
- NCT07675265
- 其他研究编号
- CLN-10, 75A50125C00016
日期
- 首次提交
- (3个月前)
- 首次发布
- (3个月前)
- 主要完成日期
- (2年后)
- 研究完成日期
- (2年后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
相似试验
Unknown
3 期
同适应症Effects of Sevoflurane on Extravascular Lung Water and Pulmonary Vascular Permeability in Patients With ARDSARDS, HumanARDSNCT04530188Bicetre Hospital68
Unknown
不适用
同适应症The Evaluation of NETs, Caspase-1 and Cytokines in ARDS PatientsARDSNCT03227107Xiangya Hospital of Central South University100
已完成
2 期
同适应症Safety and Preliminary Efficacy of Sequential Multiple Ascending Doses of Solnatide to Treat Pulmonary Permeability Oedema in Patients With Moderate-to-severe ARDSARDSNCT03567577Apeptico Forschung und Entwicklung GmbH92
终止
4 期
同适应症Paediatric Ards Neuromuscular Blockade StudyARDSNCT02902055University Medical Center Groningen3
Unknown
不适用
同适应症Ventilatory Efficiency in Critically Ill COVID-19 PatientsARDSNCT04694742ASST Fatebenefratelli Sacco100