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Completed

NCT Number: NCT04318691

Netosis in Determination of Respiratory Infection Severity

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de médecine intensive réanimation, Hôpital Ambroise Paré, APHP

Boulogne-Billancourt, 92100, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sampling

Biological

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

Bronchoalveolar lavage

Procedure

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: NETMINDERS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 24, 2020
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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