Clinical trial
Interleukine 6 (IL6) Assay for Predicting Failure of Spontaneous Breathing in Patients With COVID-19 Acute Respiratory Distress Syndrome
Name
COVIL6
Description
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the increase in IL6 is a negative prognosis during medical first aid but also when the mechanical ventilation is withdrawn.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.
Trial arms
Trial start
2021-08-05
Estimated PCD
2022-03-24
Trial end
2022-12-31
Status
Terminated
Treatment
IL6 assessment
Blood IL6 will be assessed during trial
Arms:
Patients with COVID-19 acute respiratory distress syndrome
CRP and PCT assessment
Blood CRP and PCT will be assessed during trial
Arms:
Patients with COVID-19 acute respiratory distress syndrome
Size
35
Primary endpoint
Serum concentration of IL6
Up to 72 hours after the start of respiratory weaning
Eligibility criteria
Inclusion Criteria:
* Age\>18 years
* Patients with COVID-19 (positive COVID PCR)
* Use of intubation for mechanical ventilation
Exclusion Criteria:
* Use of Extracorporeal Membrane Oxygenation
* Treatment with Tocilizumab (anti-Il6)
* Pregnant woman
* Patients under protective administration or deprived of liberty
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 35, 'type': 'ACTUAL'}}
Updated at
2024-05-13
1 organization
2 products
1 indication
Organization
Centre Hospitalier Henri DuffautProduct
IL6Indication
COVID-19 ARDSProduct
CRP and PCT assessment