Clinical Trials Directory

Trials / Terminated

TerminatedNCT05330845

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
35 (actual)
Sponsor
Centre Hospitalier Henri Duffaut - Avignon · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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the increase in IL6 is a negative prognosis during medical first aid but also when the mechanical ventilation is withdrawn.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

Interventions

TypeNameDescription
BIOLOGICALIL6 assessmentBlood IL6 will be assessed during trial
BIOLOGICALCRP and PCT assessmentBlood CRP and PCT will be assessed during trial

Timeline

Start date
2021-08-05
Primary completion
2022-03-24
Completion
2022-12-31
First posted
2022-04-15
Last updated
2024-05-13

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05330845. Inclusion in this directory is not an endorsement.