Netosis in Determination of Respiratory Infection Severity
- Conditions
- Respiratory Infection
- Interventions
- Biological: Blood samplingProcedure: Bronchoalveolar lavage
- Registration Number
- NCT04318691
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Not provided
A/ For all subjets:
- pregnancy,
- nosocomial pneumonia,
- no social health insurance,
- neutropenia of any cause;
- patient refusal.
B/ Exclusion criteria for acute respiratory failure patients:
- no mechanical ventilation within the first 24 hours after admission to the ICU.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description acute respiratory failure group Blood sampling 60 patients under mechanical ventilation admitted to the intensive care unit for acute respiratory failure acute respiratory failure group Bronchoalveolar lavage 60 patients under mechanical ventilation admitted to the intensive care unit for acute respiratory failure vascular surgery control group Blood sampling 10 control patients admitted to the ICU after a planned vascular surgery Healthy volunteers group Blood sampling 10 healthy subjects.
- Primary Outcome Measures
Name Time Method Acute respiratory distress syndrome occurrence at day-7 Acute respiratory distress syndrome occurrence according to the Berlin definition within the first 7 days after ICU admission
- Secondary Outcome Measures
Name Time Method Mortality At day-28 Vital statue of patient
Duration of mechanical ventilation At day-28 Duration of mechanical ventilation: number of days without mechanical ventilation.
IGSII score At admission to ICU IGSII score
SOFA score At admission to ICU SOFA score
Hemodynamic failure At day-28 Development of a hemodynamic failure
Pulmonary circulation failure At day-28 Development of a pulmonary circulation failure (acute pulmonary heart disease, right ventricle failure)
Trial Locations
- Locations (1)
Service de médecine intensive réanimation, Hôpital Ambroise Paré, APHP
🇫🇷Boulogne-Billancourt, France