Skip to content

Netosis in Determination of Respiratory Infection Severity

Netosis in Mechanically Ventilated ICU Patients in Determination of Respiratory Infection Severity

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04318691
Acronym
NETMINDERS
Enrollment
80
Registered
2020-03-24
Start date
2022-06-07
Completion date
2023-01-03
Last updated
2023-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Infection

Keywords

acute respiratory distress syndrome, adult ICU, neutrophil extracellular traps (NETs), Netosis, neutrophils, mechanical ventilation, pneumonia

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.

Interventions

BIOLOGICALBlood sampling

Blood sampling at baseline and at day-3 (10 ml, EDTA tube), test of NETs.

PROCEDUREBronchoalveolar lavage

Bronchoalveolar lavage at admission to the ICU with analysis of cytological, bacteriological, viral and anatomopathological, and test of NETs.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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/

Design outcomes

Primary

MeasureTime frameDescription
Acute respiratory distress syndrome occurrenceat day-7Acute respiratory distress syndrome occurrence according to the Berlin definition within the first 7 days after ICU admission

Secondary

MeasureTime frameDescription
Duration of mechanical ventilationAt day-28Duration of mechanical ventilation: number of days without mechanical ventilation.
IGSII scoreAt admission to ICUIGSII score
MortalityAt day-28Vital statue of patient
Hemodynamic failureAt day-28Development of a hemodynamic failure
Pulmonary circulation failureAt day-28Development of a pulmonary circulation failure (acute pulmonary heart disease, right ventricle failure)
SOFA scoreAt admission to ICUSOFA score

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026