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

NCT ID: NCT05330845

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-05
• Study Completion Date: 2022-12-31

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the increase in IL6 is a negative prognosis during medical first aid but also when the mechanical ventilation is withdrawn.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

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with COVID-19 acute respiratory distress syndrome

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

Group Type: OTHER

IL6 assessment

Intervention Type: BIOLOGICAL

Blood IL6 will be assessed during trial

CRP and PCT assessment

Intervention Type: BIOLOGICAL

Blood CRP and PCT will be assessed during trial

Interventions

IL6 assessment

Blood IL6 will be assessed during trial

Intervention Type: BIOLOGICAL

CRP and PCT assessment

Blood CRP and PCT will be assessed during trial

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Henri Duffaut - Avignon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas POUSSARD, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Henri Duffaut - Avignon

Estelle DELAUNAY, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Henri Duffaut - Avignon

Locations

Centre Hospitalier Henri Duffaut

Avignon, Vaucluse, France

Countries

France

Other Identifiers

COVIL6

Identifier Type: -

Identifier Source: org_study_id