Interleukine 6 (IL6) Assay for Predicting Failure of Spontaneous Breathing in Patients With COVID-19 Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Serum concentration of IL6
研究概览
简要总结
In the current COVID-19 pandemic, many patients have an acute respiratory distress syndrome (ARDS). Among mechanisms related to COVID-19 acute respiratory distress syndrome, cytokine storm and secretion of IL-6 play a central role. ARDS management involves intubation for protective mechanical ventilation, deep sedation and curarisation.
During intensive care unit (ICU) hospitalization, improvement of hematosis induces a switch from a controlled ventilation mode to a withdrawal ventilation mode, such as Spontaneous Ventilation with Pressure Support (SP-PS) or Adaptative Support Ventilation (ASV). This step is essential prior to considering complete weaning from controlled ventilation and sometimes ends with a failure. In this case, deterioration of hematosis and/or ventilatory mechanics is observed.
At the same time as withdrawal failure, the investigators observed biological inflammatory rebound in some patients. Therefore, influence of inflammatory biological parameters, including IL-6, on withdrawal failure, needs to be investigated. To this end, the investigators decide to dose different inflammatory markers - such as IL6, C-Reactive Protein (CRP), Procalcitonin (PCT) - in patients with acute respiratory distress syndrome due to COVID-19, during standard of care. Indeed, in patients with acute respiratory distress syndrome not due to COVID-19, the increase in IL6 is a negative prognosis during medical first aid but also when the mechanical ventilation is withdrawn. In addition, IL6 rise is associated with poor prognosis for patients with COVID-19 and longer stays in intensive care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Patients with COVID-19 (positive COVID PCR)
- •Use of intubation for mechanical ventilation
排除标准
- •Use of Extracorporeal Membrane Oxygenation
- •Treatment with Tocilizumab (anti-Il6)
- •Pregnant woman
- •Patients under protective administration or deprived of liberty
研究组 & 干预措施
Patients with COVID-19 acute respiratory distress syndrome
Patients with acute respiratory distress syndrome due to COVID-19 and requiring mechanical ventilation
干预措施: IL6 assessment (Biological)
Patients with COVID-19 acute respiratory distress syndrome
Patients with acute respiratory distress syndrome due to COVID-19 and requiring mechanical ventilation
干预措施: CRP and PCT assessment (Biological)
结局指标
主要结局
Serum concentration of IL6
时间窗: Up to 72 hours after the start of respiratory weaning
Change of blood IL6 concentration during switch from a controlled ventilation mode to a weaning ventilation mode in COVID-19 patients
次要结局
- Days of mechanical ventilation(At the start of respiratory weaning)
- Number of ventral decubitus(At the start of respiratory weaning)
- Pulmonary wedge pressure(Up to 48 hours after the start of respiratory weaning)
- Fraction of inspired oxygen(Up to 48 hours after the start of respiratory weaning)
- Serum concentration of CRP and PCT(Up to 48 hours after the start of respiratory weaning)
- Respiratory rate(Up to 48 hours after the start of respiratory weaning)
- Tidal Volume(Up to 48 hours after the start of respiratory weaning)