Clinical trial NCT05330845: Interleukine 6 (IL6) Assay for Predicting Failure of Spontaneous Breathing in Patients With COVID-19 Acute Respiratory Distress Syndrome
Official title: Interleukine 6 (IL6) Assay for Predicting Failure of Spontaneous Breathing in Patients With COVID-19 Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COVID-19 Acute Respiratory Distress Syndrome
Keywords: Interleukin-6
Acute Respiratory Distress Syndrome
COVID-19
Lead sponsor: Centre Hospitalier Henri Duffaut - Avignon
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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the increase in IL6 is a negative prognosis during medical first aid but also when the mechanical ventilation is withdrawn.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.


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

Primary outcomes:
measure: Serum concentration of IL6
timeFrame: Up to 72 hours after the start of respiratory weaning
Secondary outcomes:
measure: Serum concentration of CRP and PCT
timeFrame: Up to 48 hours after the start of respiratory weaning
measure: Pulmonary wedge pressure
timeFrame: Up to 48 hours after the start of respiratory weaning
measure: Respiratory rate
timeFrame: Up to 48 hours after the start of respiratory weaning
measure: Fraction of inspired oxygen
timeFrame: Up to 48 hours after the start of respiratory weaning
measure: Tidal Volume
timeFrame: Up to 48 hours after the start of respiratory weaning
measure: Days of mechanical ventilation
timeFrame: At the start of respiratory weaning
measure: Number of ventral decubitus
timeFrame: At the start of respiratory weaning
Other outcomes:
Locations:
city: Avignon
country: France
facility: Centre Hospitalier Henri Duffaut
state: Vaucluse
Study officials:
affiliation: Centre Hospitalier Henri Duffaut - Avignon
name: Nicolas POUSSARD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Henri Duffaut - Avignon
name: Estelle DELAUNAY, MD
role: PRINCIPAL_INVESTIGATOR
References: