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

Sponsor

Centre Hospitalier Henri Duffaut - Avignon (Other)

Overall Status

Recruiting

CT.gov ID

NCT05330845

Collaborator

(none)

Enrollment

Location

Arm

16.8

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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the increase in IL6 is a negative prognosis during medical first aid but also when the mechanical ventilation is withdrawn.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

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Acute Respiratory Distress Syndrome	Biological: IL6 assessment Biological: CRP and PCT assessment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

94 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Aug 8, 2021

Anticipated Primary Completion Date :

Aug 8, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Patients with COVID-19 acute respiratory distress syndrome Patients with acute respiratory distress syndrome due to COVID-19 and requiring mechanical ventilation	Biological: IL6 assessment Blood IL6 will be assessed during trial Biological: CRP and PCT assessment Blood CRP and PCT will be assessed during trial

Arm

Intervention/Treatment

Other: Patients with COVID-19 acute respiratory distress syndrome

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

Biological: IL6 assessment

Blood IL6 will be assessed during trial

Biological: CRP and PCT assessment

Blood CRP and PCT will be assessed during trial

Outcome Measures

Primary Outcome Measures

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

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
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
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
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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Henri Duffaut	Avignon	Vaucluse	France	84000

Sponsors and Collaborators

Centre Hospitalier Henri Duffaut - Avignon

Investigators

Principal Investigator: Nicolas POUSSARD, MD, Centre Hospitalier Henri Duffaut - Avignon
Principal Investigator: Estelle DELAUNAY, MD, Centre Hospitalier Henri Duffaut - Avignon