Pulmonary Fibrosis Biomarkers During Exacerbation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Extension of the PFBIO cohort which includes patients with newly diagnosed idiopathic pulmonary fibrosis (IPF) for longitudinal follow-up for up to 5 years.
In the PFBIO-EXA extension, patients are included if they experience an exacerbation, or other increase in respiratory symptoms requiring hospital admission, for further collection of clinical and biological data.
详细描述
The aim of this study is to investigate the diagnostic and prognostic value of clinical and blood biomarkers during exacerbations, or other increase in respiratory symptoms requiring hospital admission in patients with IPF.
Patients that are already included in the PFBIO-cohort (NCT02755441) and who are admitted to hospital with an increase in respiratory symptoms, are also included in PFBIO-EXA.
Patients are recruited within 24 hrs. from hospital admission with respiratory worsening, where clinical data, and blood samples are collected. The blood samples are investigated for the same blood biomarkers as PFBIO.
Patient related outcomes are also collected, including quality-of-life questionnaires and outcomes of the exacerbations.
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
- 否
入选标准
- •Admitted with an increase in respiratory symptoms
- •Already included in PFBIO or included simultaneously in PFBIO and PFBIO-EXA
- •Age at least 18 years
排除标准
- •Unable to provide informed consent
结局指标
主要结局
Mortality
时间窗: 90 days
All-cause mortality
次要结局
- Decline in functional level(30 days)
- Treatment during hospitalization(30 days)
- QoL(30 days)
- Respiratory support(30 days)
- Biomarker levels(30 days)
- LTOT(30 days)
- Treatment after hospitalization(90 days)
研究者
Nils Hoyer
Principal Investigator
University Hospital, Gentofte, Copenhagen