Service de médecine intensive réanimation, Hôpital Ambroise Paré, APHP
Boulogne-Billancourt, 92100, France
NCT Number: NCT04318691
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.
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Notify Me18 year and older
All sexes
Observational
Boulogne-Billancourt, 92100, France
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 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
A/ For all subjets:
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:
C/ Inclusion criteria for control patients:
Exclusion criteria
A/ For all subjets:
B/ Exclusion criteria for acute respiratory failure patients:
Blood sampling at baseline and at day-3 (10 ml, EDTA tube), test of NETs.
Bronchoalveolar lavage at admission to the ICU with analysis of cytological, bacteriological, viral and anatomopathological, and test of NETs.
Time frame: at day-7
Acute respiratory distress syndrome occurrence according to the Berlin definition within the first 7 days after ICU admission
Time frame: At day-28
Vital statue of patient
Time frame: At day-28
Duration of mechanical ventilation: number of days without mechanical ventilation.
Time frame: At admission to ICU
IGSII score
Time frame: At admission to ICU
SOFA score
Time frame: At day-28
Development of a hemodynamic failure
Time frame: At day-28
Development of a pulmonary circulation failure (acute pulmonary heart disease, right ventricle failure)
Assistance Publique - Hôpitaux de Paris
Other
Netosis in Mechanically Ventilated ICU Patients in Determination of Respiratory Infection Severity
Acronym: NETMINDERS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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