Netosis in Determination of Respiratory Infection Severity
NCT ID: NCT04318691
Last Updated: 2023-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2022-06-07
2023-01-03
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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acute respiratory failure group
60 patients under mechanical ventilation admitted to the intensive care unit for acute respiratory failure
Blood sampling
Blood sampling at baseline and at day-3 (10 ml, EDTA tube), test of NETs.
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
Blood sampling
Blood sampling at baseline and at day-3 (10 ml, EDTA tube), test of NETs.
Healthy volunteers group
10 healthy subjects.
Blood sampling
Blood sampling at baseline and at day-3 (10 ml, EDTA tube), test of NETs.
Interventions
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Blood sampling
Blood sampling at baseline and at day-3 (10 ml, EDTA tube), test of NETs.
Bronchoalveolar lavage
Bronchoalveolar lavage at admission to the ICU with analysis of cytological, bacteriological, viral and anatomopathological, and test of NETs.
Eligibility Criteria
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Inclusion Criteria
* Be \>/= 18 years of age on day of signing informed consent;
* Affiliated to the french social security - welfare system in France.
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.
\- admitted to the ICU for post-operative management of vascular surgery.
Exclusion Criteria
* pregnancy,
* nosocomial pneumonia,
* no social health insurance,
* neutropenia of any cause;
* patient refusal.
\- no mechanical ventilation within the first 24 hours after admission to the ICU.
18 Years
ALL
Yes
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Edouard JULLIEN, MD
Role: PRINCIPAL_INVESTIGATOR
Service de médecine intensive réanimation, Hôpital Ambroise Paré, APHP
Guillaume Geri, MD, PhD
Role: STUDY_DIRECTOR
Service de médecine intensive réanimation, Hôpital Ambroise Paré, APHP
Locations
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Service de médecine intensive réanimation, Hôpital Ambroise Paré, APHP
Boulogne-Billancourt, , France
Countries
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Other Identifiers
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2020-A00217-32
Identifier Type: -
Identifier Source: org_study_id
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