Pulmonary Inflammation Profiles in COVID-19 Related ARDS
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Patients older than 18 years of age, with COVID-19 related ARDS (C-ARDS) hospitalized in the ICU and invasively mechanically ventilated will be included in the study.
This is an observational cohort study. After informed consent by the next of kin, and within the first 72 hours of invasive mechanical ventilation a blood and a Broncho Alveolar Lavage Fluid (BALF) sample will be collected. If the patients remain invasively mechanically ventilated a second and third blood and BALF sample will be collected every 7-10 days.
详细描述
The main objective of the core study is to measure a number of biochemical, cellular and inflammatory mediators in the BALF of C-ARDS patients and evaluate their correlation with the course of disease in terms of respiratory mechanics, complications and outcomes.
The mediators selected have been previously used in ARDS investigation to attempt prognostic and predictive enrichment.
Patients hospitalized in the ICU following C-ARDS and requiring invasive mechanical ventilation will be candidates for enrollment.
Patients enrolled in the study (Informed consent obtained from next of kin) will be subject to the realization of optic bronchoscopy within the first 72 h of mechanical ventilation to obtain BALF for analysis. A second and third bronchoscopy and sampling of BALF will be performed every 7-10 days if mechanical ventilation and the clinical conditions allow it. A sample of whole blood will be taken contemporary to each bronchoscopy in order to perform parallel measurements (lungs and peripheral blood). Patients will be followed up until hospital discharge.
BALF samples will be divided to perform different analysis in the immunology, cytology and microbiology labs.
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
- •Age > 18 years old
- •COVID-19 related ARDS
- •Hospitalized in ICU
- •Invasive mechanical ventilation
排除标准
- •Immunocompromised for previous condition
- •transplanted patients
- •Known pulmonary bacterial co-infection at the time of admission to the ICU
- •Contraindication to the realization of Bronchoscopy (Itracranial Hypertension, severe hypoxaemia with P/F < 80, severe hemodynamic instability, severe arrhythmia, non correctable coagulopathy)
结局指标
主要结局
Mortality
时间窗: Up to 3 months
Correlation of BALF and Blood mediators with ICU mortality
次要结局
- BALF PCR(Day 0 (performance of first BALF sample) Day 8, Day 16)
- BALF characteristics(Day 0 (performance of first BALF sample) Day 8, Day 16)
- BALF cytoquines(Day 0 (performance of first BALF sample) Day 8, Day 16)
- Respiratory mechanics(Day 0 (after study inclusion) and every day up to 3 months)
研究者
Tommaso Bardi
Principal Investigator
Hospital Universitario Ramon y Cajal