Pulmonary Microbiota and ARDS Mortality

• Conditions: Acute Respiratory Distress Syndrome

• Registration Number: NCT04133558
• Lead Sponsor: University of Bordeaux

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.

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-17
• Study First Posted: 2019-10-21
• Study Start: 2019-10-31
• Last Update Submitted: 2019-10-31
• Last Update Posted: 2019-11-01
• Primary Completion: 2020-11-01
• Study Completion: 2020-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
lung bacteriobiota and ICU mortality	at admission	Comparison of lung bacteriobiota alpha diversity between ARDS ICU survivors and non-survivors

Secondary Outcome Measures

Name	Time	Method
bacteria and ICU mortality	at admission	Association of bacteria with ARDS ICU mortality by LefSe method
fungi and 1-month mortality	microbiota : at admission, mortality: 1 month after inclusion	Association of fungi with ARDS 1-month mortality by LefSe method
lung bacteriobiota and ICU mortality	at admission	Analysis of lung bacteriobiota beta diversity between ARDS ICU survivors and non-survivors
bacteria and 1-month mortality	microbiota : at admission, mortality: 1 month after inclusion	Association of bacteria with ARDS 1-month mortality by LefSe method
lung mycobiota and ICU mortality	at admission	Analysis of lung mycobiota beta diversity between ARDS ICU survivors and non-survivors
lung mycobiota and 1-month mortality	microbiota : at admission, mortality: 1 month after inclusion	Analysis of lung mycobiota beta diversity between ARDS 1-month survivors and non-survivors
lung bacteriobiota and 1-month mortality	microbiota : at admission, mortality: 1 month after inclusion	Analysis of lung bacteriobiota beta diversity between ARDS 1-month survivors and non-survivors
fungi and ICU mortality	at admission	Association of fungi with ARDS ICU mortality by LefSe method

Trial Locations

Locations (1)

Medical intensive care unit, Pellegrin hospital; 🇫🇷 Bordeaux, Nouvelle-Aquitaine, France