Acute Pulmonary and Systemic Inflammation in Mechanically Ventilated Intensive Care Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Tumor necrosis factor alpha (TNF-a) bioactivity
研究概览
简要总结
Acute respiratory distress syndrome (ARDS) is a devastating form of acute lung inflammation, that may be caused by a variety of insults with pulmonary and systemic infectious disease being the most common predisposing factor. Sepsis, on the other hand, represents the systemic inflammatory response to an invading pathogen, which may inflict damage upon the host through organ dysfunction. ARDS and sepsis are heterogenous clinical conditions that have a high mortality, and both diseases involve a complex interplay of different inflammatory mediators and cell types. It has been suggested that locally released inflammatory mediators pass from the lungs into the bloodstream following ARDS, triggering systemic inflammation. Conversely, it is possible that severe systemic inflammation may lead to ARDS by an influx of inflammatory mediators from the bloodstream to the lungs. However, the time course and the possible pathways for this transmission of disease have yet to be established.
Investigators hypothesize that:
- Primary systemic inflammation is followed by a secondary pulmonary inflammatory response
- Primary pulmonary inflammation is followed by a secondary systemic inflammatory response
- Both primary and secondary inflammatory responses are characterized by the appearance of pro-inflammatory cytokines, inflammatory cells and production of collagen-like proteins (termed 'lectins')
- The inflammatory response is most pronounced in the primary afflicted compartment.
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
- •Mechanically ventilated
- •< 48 hours after admission to the Intensive Care Unit
- •ARDS: acute (< 1 week) respiratory failure, characterized by hypoxemia (PaO2/FiO2 < 300 mmHg/40kPa), and bilateral infiltrates on x-ray or CT of thorax, that can not be explained by heart failure og overhydration.
- •SIRS (two of the following): Temperature > 38°C or < 36°C, heart rate > 90/min, respiratory frequency > 20 or PaCO2 < 4.2 kPa, leukocytosis (> 12x10^9/L) or leukopenia (< 4x10^9/L)
- •ARDS + SIRS
排除标准
- •One lung ventilation; Tube size < 8.0 mm; INR > 1.5 or thrombocytes < 40x10^9/L; Intracranial hypertension; Malignant arrythmias
结局指标
主要结局
Tumor necrosis factor alpha (TNF-a) bioactivity
时间窗: Day fourteen
次要结局
- Ficolin-1,2,3(Day one)
- Interleukin (IL)-6(Day one)
- Mannose binding lectin (MBL)(Day one)
研究者
Ronni R. Plovsing
MD
Rigshospitalet, Denmark