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

NCT05330845 | Terminated

• 1 other identifier: COVIL6
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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the increase in IL6 is a negative prognosis during medical first aid but also when the mechanical ventilation is withdrawn.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

Keywords

Interleukin-6; Acute Respiratory Distress Syndrome; COVID-19

Outcome Measures

Primary Outcomes (1)

• Serum concentration of IL6

  Change of blood IL6 concentration during switch from a controlled ventilation mode to a weaning ventilation mode in COVID-19 patients

  Up to 72 hours after the start of respiratory weaning

Secondary Outcomes (7)

• Serum concentration of CRP and PCT

  Up to 48 hours after the start of respiratory weaning

• Pulmonary wedge pressure

  Up to 48 hours after the start of respiratory weaning

• Respiratory rate

  Up to 48 hours after the start of respiratory weaning

• Fraction of inspired oxygen

  Up to 48 hours after the start of respiratory weaning

• Tidal Volume

  Up to 48 hours after the start of respiratory weaning

Study Arms (1)

Patients with COVID-19 acute respiratory distress syndrome

OTHER

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

Biological: IL6 assessment; Biological: CRP and PCT assessment

Interventions

IL6 assessment BIOLOGICAL

Blood IL6 will be assessed during trial

Patients with COVID-19 acute respiratory distress syndrome

CRP and PCT assessment BIOLOGICAL

Blood CRP and PCT will be assessed during trial

Patients with COVID-19 acute respiratory distress syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18 years
• Patients with COVID-19 (positive COVID PCR)
• Use of intubation for mechanical ventilation

You may not qualify if:

• Use of Extracorporeal Membrane Oxygenation
• Treatment with Tocilizumab (anti-Il6)
• Pregnant woman
• Patients under protective administration or deprived of liberty

Sponsors & Collaborators

• Centre Hospitalier Henri Duffaut - Avignon: lead

Study Sites (1)

Centre Hospitalier Henri Duffaut

Avignon, Vaucluse, 84000, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Nicolas POUSSARD, MD

  Centre Hospitalier Henri Duffaut - Avignon

  PRINCIPAL INVESTIGATOR

• Estelle DELAUNAY, MD

  Centre Hospitalier Henri Duffaut - Avignon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 15, 2022
• Study Start: August 5, 2021
• Primary Completion: March 24, 2022
• Study Completion: December 31, 2022
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)