Netosis in Determination of Respiratory Infection Severity

Respiratory Infection Clinical Trial

— NETMINDERS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04318691
• Other study ID #: 2020-A00217-32
• Status: Completed
• Start date: June 7, 2022
• Est. completion date: January 3, 2023

Study information

• Verified date: March 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 3, 2023
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Respiratory Infection
• Respiratory Tract Infections

Intervention

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.

Locations

Country	Name	City	State
France	Service de médecine intensive réanimation, Hôpital Ambroise Paré, APHP	Boulogne-Billancourt

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality	Vital statue of patient	At day-28
Secondary	Duration of mechanical ventilation	Duration of mechanical ventilation: number of days without mechanical ventilation.	At day-28
Secondary	IGSII score	IGSII score	At admission to ICU
Secondary	SOFA score	SOFA score	At admission to ICU
Secondary	Hemodynamic failure	Development of a hemodynamic failure	At day-28
Secondary	Pulmonary circulation failure	Development of a pulmonary circulation failure (acute pulmonary heart disease, right ventricle failure)	At day-28