Clinical trial NCT04133558: Pulmonary Microbiota and ARDS Mortality
Official title: Association of Lung Microbiota With Intensive Care Unit Mortality in ARDS Patients: MicrA Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Respiratory Distress Syndrome
Keywords: acute respiratory distress syndrome
microbiota
intensive care unit
Lead sponsor: University of Bordeaux
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ARDS patients needing oro-tracheal intubation for mechanical ventilation in ICU

Brief summary: Acute respiratory distress syndrome (ARDS) is due to diffuse and severe lung inflammation. Despite intensive research, few therapeutics have emerged and treatment is still mostly symptomatic. As lung microbiota seems to be associated with lung inflammation in numerous chronic respiratory diseases, this study aims to analyse the correlation between lung microbiota and mortality.

Detailed description: ARDS is caused by diffuse intense lun inflammation. Its mortality rate is still about 40%. Despite decades of research, few therapeutics have emerged. Treatment is based on the treatment of ARDS cause, if possible and on protective ventilation, curare use and prone position. For more severe cases, nitric monoxide inhalation and extra-corporeal membrane oxygenation can be considered. Nevertheless, no treatment specifically addresses lung inflammation. Lung microbiota has been shown to be associated with lung inflammation in asthma, chronic obstructive disease and cystic fibrosis. Lung microbiota also plays a role in lung immunity. Regarding specifically ARDS, one study correlated lung microbiota with the occurrence of non-infectious ARDS in trauma patients. Thi study therefore aims to analyse the correlation between lung microbiota at admission to ICU for ARDS with mortality.

Eligibility criteria: Inclusion Criteria:

* Patient above 18 year-old admitted to intensive care unit
* ARDS according to Berlin criteria
* Needing oro-tracheal intubation for mechanical ventilation
* Within the first 48 hours of ARDS evolution

Exclusion Criteria:

* Guardianship or curatorship
* Prisoners
* No health insurance
* No legal representative

Primary outcomes:
measure: lung bacteriobiota and ICU mortality
timeFrame: at admission
Secondary outcomes:
measure: lung mycobiota and ICU mortality
timeFrame: at admission
measure: lung mycobiota and 1-month mortality
timeFrame: microbiota : at admission, mortality: 1 month after inclusion
measure: lung bacteriobiota and ICU mortality
timeFrame: at admission
measure: lung bacteriobiota and 1-month mortality
timeFrame: microbiota : at admission, mortality: 1 month after inclusion
measure: lung mycobiota and ICU mortality
timeFrame: at admission
measure: lung mycobiota and 1-month mortality
timeFrame: microbiota : at admission, mortality: 1 month after inclusion
measure: bacteria and ICU mortality
timeFrame: at admission
measure: bacteria and 1-month mortality
timeFrame: microbiota : at admission, mortality: 1 month after inclusion
measure: fungi and ICU mortality
timeFrame: at admission
measure: fungi and 1-month mortality
timeFrame: microbiota : at admission, mortality: 1 month after inclusion
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Medical intensive care unit, Pellegrin hospital
state: Nouvelle-Aquitaine
Study officials:
References: