Netosis in Determination of Respiratory Infection Severity

NCT04318691 | Completed

• 1 other identifier: 2020-A00217-32
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Acute respiratory distress syndrome occurrence

  Acute respiratory distress syndrome occurrence according to the Berlin definition within the first 7 days after ICU admission

  at day-7

Secondary Outcomes (6)

• Mortality

  At day-28

• Duration of mechanical ventilation

  At day-28

• IGSII score

  At admission to ICU

• SOFA score

  At admission to ICU

• Hemodynamic failure

  At day-28

Study Arms (3)

acute respiratory failure group

60 patients under mechanical ventilation admitted to the intensive care unit for acute respiratory failure

Biological: Blood sampling; Procedure: Bronchoalveolar lavage

vascular surgery control group

10 control patients admitted to the ICU after a planned vascular surgery

Biological: Blood sampling

Healthy volunteers group

10 healthy subjects.

Biological: Blood sampling

Interventions

Blood sampling BIOLOGICAL

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

Healthy volunteers group; acute respiratory failure group; vascular surgery control group

Bronchoalveolar lavage PROCEDURE

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

acute respiratory failure group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• A/ For all subjets:
• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de médecine intensive réanimation, Hôpital Ambroise Paré, APHP

Boulogne-Billancourt, 92100, France

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Respiratory Distress Syndrome; Pneumonia

Interventions

Blood Specimen Collection; Bronchoalveolar Lavage

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Therapeutic Irrigation

Study Officials

• Edouard JULLIEN, MD

  Service de médecine intensive réanimation, Hôpital Ambroise Paré, APHP

  PRINCIPAL INVESTIGATOR

• Guillaume Geri, MD, PhD

  Service de médecine intensive réanimation, Hôpital Ambroise Paré, APHP

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 24, 2020
• Study Start: June 7, 2022
• Primary Completion: January 3, 2023
• Study Completion: January 3, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)