Early and Late Pulmonary and Systemic Inflammation in Critically Ill, Mechanically Ventilated Patients With Verified COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Lymphocyte populations
研究概览
简要总结
The aim of the present study is to examine the inflammatory response in the pulmonary compartment and blood of critically ill patients admitted to the ICU with COVID-19.
详细描述
The mechanisms of the ARDS-like respiratory failure observed in patients with COVID-19 are currently unknown, but may be related to a distinct local immune response within the lung. In the present study, we will examine the cellular and humoral pulmonary immune response in mechanically ventilated patients admitted to the ICU with COVID-19 by examining immune cell profiles, cytokine patterns, and the complement pathway in bronchoalveolar lavage fluid, and relate it to the concomitant systemic inflammatory response. We will examine the patients on day 1-3 and 7-9 after ICU admission.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 > 18y
- •Mechanical ventilation
- •Verified COVID-19 (throat swab or tracheal aspirate positive for SARS-CoV-2)
- •ARDS according to the Berlin definition
排除标准
- •Untreated malignant tachycardia or bradycardia
- •Suspected or verified intracranial hypertension (ICP > 15 mmHg)
- •Unilateral lung ventilation
- •Severe non-correctable coagulopathy
结局指标
主要结局
Lymphocyte populations
时间窗: Day 7
Cell populations and subpopulations evaluated by 10 colored flow cytometry (B cells, T cells, TCR subsets, Tregs/Th17, dendritic cells, myeloid cells and neutrophils) in bronchoalveolar lavage fluid and blood
White blood cell counts
时间窗: Day 7
Total white blood cells, neutrocytes, lymphocytes, and monocytes in bronchoalveolar lavage fluid and blood
次要结局
- Cytokines(Day 7)
- Microorganisms(Up to 12 weeks)
- Levels of SARS-CoV-2 in the airways(Day 7)
- Autoantibodies against type I IFNs in the airways(Day 0)
- Lectin complement pathway(Day 7)
- Respiratory pathogens(Day 7)
- Ribosomal RNA in the airways(Day 7)
- Surfactant in the airways(Day 0)
研究者
Ronni R. Plovsing
MD, PhD
Hvidovre University Hospital