Trials / Completed
CompletedNCT04318691
Netosis in Determination of Respiratory Infection Severity
Netosis in Mechanically Ventilated ICU Patients in Determination of Respiratory Infection Severity
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 80 (actual)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The study aims to evaluate the prognostic value of alveolar and blood NETosis in patients under mechanical ventilation and treated for an acute low-respiratory tract infection. The main outcome is the occurrence of an acute respiratory distress syndrome (ARDS) according to the Berlin definition.
Detailed description
Neutrophils are the first line of defense against infectious injury. Among the numerous mechanisms involving the immune system, neutrophil extracellular traps (NETs) have been recently described as an additional way neutrophils are able to use to fight against bacteria. NETs are made of DNA and antimicrobial proteins. In the other hand, NETs promote coagulation and may contribute to evolution of severe pneumonia into acute respiratory distress syndrome. The secondary objectives of the study include the research of the relation between blood NETosis and alveolar NETosis with: * the documentation of invasive pulmonary infection based on microbiological analysis criteria (which would be bacteria or viral) of LBA at admission to ICU; * the diagnosis value of usually used biomarkers: procalcitonin and C-reactive protein; * marbrure score at admission to ICU; * arterial lactatemia; * scores of gravity at admission IGSII and SOFA; * all-cause mortality at day-28; * duration of mechanical ventilation at day-28; * duration of amines at day-28; * developement of hemodynamic failure; * developement of pulmonary circulatory failure. The study will include 1) 60 patients under mechanical ventilation admitted to the intensive care unit for acute respiratory failure, 2) 10 control patients admitted to the ICU after a planned vascular surgery and 3) 10 healthy subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Blood sampling | Blood sampling at baseline and at day-3 (10 ml, EDTA tube), test of NETs. |
| PROCEDURE | Bronchoalveolar lavage | Bronchoalveolar lavage at admission to the ICU with analysis of cytological, bacteriological, viral and anatomopathological, and test of NETs. |
Timeline
- Start date
- 2022-06-07
- Primary completion
- 2023-01-03
- Completion
- 2023-01-03
- First posted
- 2020-03-24
- Last updated
- 2023-03-16
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04318691. Inclusion in this directory is not an endorsement.