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Netosis in Determination of Respiratory Infection Severity (NETMINDERS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318691
Recruitment Status : Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Respiratory Infection Biological: Blood sampling Procedure: Bronchoalveolar lavage

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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Netosis in Mechanically Ventilated ICU Patients in Determination of Respiratory Infection Severity
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020


Group/Cohort 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.




Primary Outcome Measures :
  1. Acute respiratory distress syndrome occurrence [ Time Frame: at day-7 ]
    Acute respiratory distress syndrome occurrence according to the Berlin definition within the first 7 days after ICU admission


Secondary Outcome Measures :
  1. Mortality [ Time Frame: At day-28 ]
    Vital statue of patient

  2. Duration of mechanical ventilation [ Time Frame: At day-28 ]
    Duration of mechanical ventilation: number of days without mechanical ventilation.

  3. IGSII score [ Time Frame: At admission to ICU ]
    IGSII score

  4. SOFA score [ Time Frame: At admission to ICU ]
    SOFA score

  5. Hemodynamic failure [ Time Frame: At day-28 ]
    Development of a hemodynamic failure

  6. Pulmonary circulation failure [ Time Frame: At day-28 ]
    Development of a pulmonary circulation failure (acute pulmonary heart disease, right ventricle failure)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • Adult ICU patients under mechanical ventilation with suspected lower-respiratory tract infection;
  • Adult ICU patients followed vascular surgical intervention;
  • Healthy Volunteers.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318691


Contacts
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Contact: Mathieu Godement, MD +33 1 49095603 mathieu.godement@aphp.fr
Contact: Guillaume Geri, MD, PhD +33 1 49095601 guillaume.geri@aphp.fr

Locations
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France
Service de médecine intensive réanimation, Hôpital Ambroise Paré, APHP
Boulogne-Billancourt, France, 92100
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Mathieu Godement, 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
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04318691    
Other Study ID Numbers: 2020-A00217-32
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
acute respiratory distress syndrome
adult ICU
neutrophil extracellular traps (NETs)
Netosis
neutrophils
mechanical ventilation
pneumonia
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases