Interleukine 6 (IL6) Assay for Predicting Failure of Spontaneous Breathing in Patients With COVID-19 Acute Respiratory Distress Syndrome

Overview

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the increase in IL6 is a negative prognosis during medical first aid but also when the mechanical ventilation is withdrawn.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

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Other
  • Masking: None (Open Label)
• Study Primary Completion Date: August 8, 2022

Interventions

• Biological: IL6 assessment
  • Blood IL6 will be assessed during trial
• Biological: CRP and PCT assessment
  • Blood CRP and PCT will be assessed during trial

Arms, Groups and Cohorts

• Other: Patients with COVID-19 acute respiratory distress syndrome
  • Patients with acute respiratory distress syndrome due to COVID-19 and requiring mechanical ventilation

Clinical Trial Outcome Measures

Primary Measures

• Serum concentration of IL6
  • Time Frame: 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 Measures

• Serum concentration of CRP and PCT
  • Time Frame: 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
• Pulmonary wedge pressure
  • Time Frame: 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
• Respiratory rate
  • Time Frame: 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
• Fraction of inspired oxygen
  • Time Frame: 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
• Tidal Volume
  • Time Frame: 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
• Days of mechanical ventilation
  • Time Frame: At the start of respiratory weaning
  • Duration of mechanical ventilation (days)
• Number of ventral decubitus
  • Time Frame: At the start of respiratory weaning
  • Number of ventral decubitus during mechanical ventilation mode

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Centre Hospitalier Henri Duffaut – Avignon
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Nicolas POUSSARD, MD, Principal Investigator, Centre Hospitalier Henri Duffaut – Avignon
  • Estelle DELAUNAY, MD, Principal Investigator, Centre Hospitalier Henri Duffaut – Avignon
• Overall Contact(s)
  • Marilyne GRINAND, PhD, +33432759392, grinand.marilyne@ch-avignon.fr