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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05330845
Enrollment
35
Registered
2022-04-15
Start date
2021-08-05
Completion date
2022-12-31
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Keywords

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

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the increase in IL6 is a negative prognosis during medical first aid but also when the mechanical ventilation is withdrawn.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

Interventions

BIOLOGICALIL6 assessment

Blood IL6 will be assessed during trial

BIOLOGICALCRP and PCT assessment

Blood CRP and PCT will be assessed during trial

Sponsors

Centre Hospitalier Henri Duffaut - Avignon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Serum concentration of IL6Up to 72 hours after the start of respiratory weaningChange of blood IL6 concentration during switch from a controlled ventilation mode to a weaning ventilation mode in COVID-19 patients

Secondary

MeasureTime frameDescription
Pulmonary wedge pressureUp to 48 hours after the start of respiratory weaningChange 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 rateUp to 48 hours after the start of respiratory weaningChange 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 oxygenUp to 48 hours after the start of respiratory weaningChange of Fraction of inspired oxygen (FiO2, in percentage) during switch from a controlled ventilation mode to a weaning mode in COVID-19 patients
Serum concentration of CRP and PCTUp to 48 hours after the start of respiratory weaningChange of blood CRP et PCT concentration during switch from a controlled ventilation mode to a weaning mode in COVID-19 patients
Days of mechanical ventilationAt the start of respiratory weaningDuration of mechanical ventilation (days)
Number of ventral decubitusAt the start of respiratory weaningNumber of ventral decubitus during mechanical ventilation mode
Tidal VolumeUp to 48 hours after the start of respiratory weaningChange of Tidal Volume (in ml/kg) during switch from a controlled ventilation mode to a weaning mode in COVID-19 patients

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026