Interleukine 6 (IL6) Assay for Predicting Failure of Spontaneous Breathing in Patients With COVID-19 Acute Respiratory Distress Syndrome
- Conditions
- COVID-19 Acute Respiratory Distress Syndrome
- Interventions
- Biological: IL6 assessmentBiological: CRP and PCT assessment
- Registration Number
- NCT05330845
- Lead Sponsor
- Centre Hospitalier Henri Duffaut - Avignon
- Brief Summary
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the increase in IL6 is a negative prognosis during medical first aid but also when the mechanical ventilation is withdrawn.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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 35
- Age>18 years
- Patients with COVID-19 (positive COVID PCR)
- Use of intubation for mechanical ventilation
- Use of Extracorporeal Membrane Oxygenation
- Treatment with Tocilizumab (anti-Il6)
- Pregnant woman
- Patients under protective administration or deprived of liberty
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with COVID-19 acute respiratory distress syndrome IL6 assessment Patients with acute respiratory distress syndrome due to COVID-19 and requiring mechanical ventilation Patients with COVID-19 acute respiratory distress syndrome CRP and PCT assessment Patients with acute respiratory distress syndrome due to COVID-19 and requiring mechanical ventilation
- Primary Outcome Measures
Name Time Method Serum concentration of IL6 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
- Secondary Outcome Measures
Name Time Method Days of mechanical ventilation At the start of respiratory weaning Duration of mechanical ventilation (days)
Number of ventral decubitus At the start of respiratory weaning Number of ventral decubitus during mechanical ventilation mode
Pulmonary wedge pressure Up to 48 hours after the start of respiratory weaning Change of pulmonary wedge pressure (in mmHg), respiratory rate (in breaths per minute), Fraction of inspired oxygen (FiO2, in percentage), Tidal Volume (in ml/kg) during switch from a controlled ventilation mode to a weaning mode in COVID-19 patients
Fraction of inspired oxygen Up to 48 hours after the start of respiratory weaning Change of Fraction of inspired oxygen (FiO2, in percentage) during switch from a controlled ventilation mode to a weaning mode in COVID-19 patients
Serum concentration of CRP and PCT Up to 48 hours after the start of respiratory weaning Change of blood CRP et PCT concentration during switch from a controlled ventilation mode to a weaning mode in COVID-19 patients
Respiratory rate Up to 48 hours after the start of respiratory weaning Change of respiratory rate (in breaths per minute) during switch from a controlled ventilation mode to a weaning mode in COVID-19 patients
Tidal Volume Up to 48 hours after the start of respiratory weaning Change of Tidal Volume (in ml/kg) during switch from a controlled ventilation mode to a weaning mode in COVID-19 patients
Trial Locations
- Locations (1)
Centre Hospitalier Henri Duffaut
🇫🇷Avignon, Vaucluse, France