NETMINDERS: Netosis in Determination of Respiratory Infection Severity
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| acute respiratory failure group 60 patients under mechanical ventilation admitted to the intensive care unit for acute respiratory failure |
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.
|
| vascular surgery control group 10 control patients admitted to the ICU after a planned vascular surgery |
Biological: Blood sampling
Blood sampling at baseline and at day-3 (10 ml, EDTA tube), test of NETs.
|
| Healthy volunteers group 10 healthy subjects. |
Biological: Blood sampling
Blood sampling at baseline and at day-3 (10 ml, EDTA tube), test of NETs.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)
Eligibility Criteria
Criteria
Inclusion criteria:
A/ For all subjets:
-
Be >/= 18 years of age on day of signing informed consent;
-
Affiliated to the french social security - welfare system in France.
B/ Inclusion criteria for acute respiratory failure patients:
admitted to the ICU for acute respiratory failure requiring mechanical ventilation within the first 24 hours after admission and suspected to suffer from an infectious pneumonia, according to the following criteria:
-
recent fever;
-
acute respiratory failure signs (dyspnea, polypnea > 30 cycles/min, hypoxemia PaO2<65 mmHg);
-
pulmonary focal signs of auscultation;
-
evocative signs in chest radiography or chest TDM.
C/ Inclusion criteria for control patients:
- admitted to the ICU for post-operative management of vascular surgery.
Exclusion Criteria:
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Service de médecine intensive réanimation, Hôpital Ambroise Paré, APHP | Boulogne-Billancourt | France | 92100 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
- Principal Investigator: Edouard JULLIEN, MD, Service de médecine intensive réanimation, Hôpital Ambroise Paré, APHP
- Study Director: Guillaume Geri, MD, PhD, Service de médecine intensive réanimation, Hôpital Ambroise Paré, APHP
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-A00217-32