Interleukine 6 (IL6) Assay for Predicting Failure of Spontaneous Breathing in Patients With COVID-19 Acute Respiratory Distress Syndrome
Primary Purpose
COVID-19 Acute Respiratory Distress Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
IL6 assessment
CRP and PCT assessment
Sponsored by
About this trial
This is an interventional other trial for COVID-19 Acute Respiratory Distress Syndrome focused on measuring Interleukin-6, Acute Respiratory Distress Syndrome, COVID-19
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
Sites / Locations
- Centre Hospitalier Henri DuffautRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with COVID-19 acute respiratory distress syndrome
Arm Description
Patients with acute respiratory distress syndrome due to COVID-19 and requiring mechanical ventilation
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Serum concentration of CRP and PCT
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
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
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
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
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
Duration of mechanical ventilation (days)
Number of ventral decubitus
Number of ventral decubitus during mechanical ventilation mode
Full Information
NCT ID
NCT05330845
First Posted
April 7, 2022
Last Updated
April 14, 2022
Sponsor
Centre Hospitalier Henri Duffaut - Avignon
1. Study Identification
Unique Protocol Identification Number
NCT05330845
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2021 (Actual)
Primary Completion Date
August 8, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Henri Duffaut - Avignon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Acute Respiratory Distress Syndrome
Keywords
Interleukin-6, Acute Respiratory Distress Syndrome, COVID-19
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with COVID-19 acute respiratory distress syndrome
Arm Type
Other
Arm Description
Patients with acute respiratory distress syndrome due to COVID-19 and requiring mechanical ventilation
Intervention Type
Biological
Intervention Name(s)
IL6 assessment
Intervention Description
Blood IL6 will be assessed during trial
Intervention Type
Biological
Intervention Name(s)
CRP and PCT assessment
Intervention Description
Blood CRP and PCT will be assessed during trial
Primary Outcome Measure Information:
Title
Serum concentration of IL6
Description
Change of blood IL6 concentration during switch from a controlled ventilation mode to a weaning ventilation mode in COVID-19 patients
Time Frame
Up to 72 hours after the start of respiratory weaning
Secondary Outcome Measure Information:
Title
Serum concentration of CRP and PCT
Description
Change of blood CRP et PCT concentration during switch from a controlled ventilation mode to a weaning mode in COVID-19 patients
Time Frame
Up to 48 hours after the start of respiratory weaning
Title
Pulmonary wedge pressure
Description
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
Time Frame
Up to 48 hours after the start of respiratory weaning
Title
Respiratory rate
Description
Change of respiratory rate (in breaths per minute) during switch from a controlled ventilation mode to a weaning mode in COVID-19 patients
Time Frame
Up to 48 hours after the start of respiratory weaning
Title
Fraction of inspired oxygen
Description
Change of Fraction of inspired oxygen (FiO2, in percentage) during switch from a controlled ventilation mode to a weaning mode in COVID-19 patients
Time Frame
Up to 48 hours after the start of respiratory weaning
Title
Tidal Volume
Description
Change of Tidal Volume (in ml/kg) during switch from a controlled ventilation mode to a weaning mode in COVID-19 patients
Time Frame
Up to 48 hours after the start of respiratory weaning
Title
Days of mechanical ventilation
Description
Duration of mechanical ventilation (days)
Time Frame
At the start of respiratory weaning
Title
Number of ventral decubitus
Description
Number of ventral decubitus during mechanical ventilation mode
Time Frame
At the start of respiratory weaning
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marilyne GRINAND, PhD
Phone
+33432759392
Email
grinand.marilyne@ch-avignon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas POUSSARD, MD
Organizational Affiliation
Centre Hospitalier Henri Duffaut - Avignon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Estelle DELAUNAY, MD
Organizational Affiliation
Centre Hospitalier Henri Duffaut - Avignon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Henri Duffaut
City
Avignon
State/Province
Vaucluse
ZIP/Postal Code
84000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marilyne GRINAND, PhD
Phone
+33432759392
Email
grinand.marilyne@ch-avignon.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Interleukine 6 (IL6) Assay for Predicting Failure of Spontaneous Breathing in Patients With COVID-19 Acute Respiratory Distress Syndrome
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