Study of the Effects of Bronchoalveolar Lavage Liquid in the ARDS on the Functioning of the Neutrophil Polynuclear System

NCT ID: NCT04008225

Last Updated: 2019-07-08

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-05

Study Completion Date

2016-05-05

Brief Summary

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Firstly, the study assesses the effect of bronchoalveolar lavage fluid (BAL) from patients in (acute respiratory distress syndrome (ARDS) on the life span of PNNs and on the phagocytosis of apoptotic cells by macrophages and polynuclear neutrophil (PNN).

Then, the effect of an antibody directed against "high-mobility group box 1" protein (HMGB1) and the effect of metformin on efferocytosis are studied.

Detailed Description

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ARDS (acute respiratory distress syndrome) is a syndrome that causes significant mortality and morbidity. This syndrome is characterized by an alveolitis with polynuclear neutrophil (PNN). PNNs play an important role in the persistence and in injuries induced by ARDS. Several animal studies have shown that lesional edema can be increased by two important mechanisms: the increase in the lifespan of PNNs in the lung and the decrease in the phagocytosis capacities of apoptotic cells (efferocytosis) by macrophages and PNNs.

However, confirmation of these data in humans does not exist, and knowledge of the mechanisms that may increase lung damage during ARDS will limit it and thus reduce the mechanical ventilation time of these patients as well as the mortality associated with ARDS.

" high-mobility group box 1 " (HMGB1) protein may be involved in reducing efferocytosis capacity. Similarly, activation of AMP-activated protein kinase (AMPk) could restore the clearance capacity of apoptotic cells in macrophages and PNNs.

Conditions

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ARDS, Human

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ARDS group

Inpatients hospitalized in medical intensive care with a table of ARDS defined according to the Berlin criteria and requiring an BAL for a diagnostic purpose under a suspicion of pneumopathy acquired under mechanical ventilation.

Bronchoalveolar lavage

Intervention Type PROCEDURE

Control group

The control group will be made up of patients with an BAL considered normal (endoscopy patients from the pneumology department). The normality of the BAL is defined by a normocellular wash with cellularity: \< 150,000 to 200,000 cells/mL Cell composition (formula): macrophages: 80-90%, lymphocytes 5 to 10% (\< 20%), neutrophils: \< 5%, eosinophils: \< 2%.

Bronchoalveolar lavage

Intervention Type PROCEDURE

Interventions

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Bronchoalveolar lavage

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ARDS Group : Inpatients hospitalized in medical intensive care with an ARDS defined according to the Berlin criteria and requiring an BAL(for diagnostic purpose in suspicion of pneumopathy acquired under mechanical ventilation).
* Control group : The control population is made up with patients with a BAL considered normal (endoscopy patients from the pneumology department). The normality of the BAL is defined by a normocellular wash with cellularity: \< 150,000 to 200,000 cells/mL Cell composition (formula): macrophages: 80-90%, lymphocytes 5 to 10% (\< 20%), neutrophils: \< 5%, eosinophils: \< 2%.

Exclusion Criteria

* Age \< 18 years;
* Pregnant women ;
* Persons deprived of their liberty by judicial or administrative decision;
* Persons legally incapable;
* Persons not affiliated to a social security system;
* Previously immunocompromised patients (HIV infection, hematopathy, organ transplantation, immunosuppression);
* Patients who do not require a lung sample.
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Marc TADIE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Rennes

Locations

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CHU de Rennes

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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35RC15_9885

Identifier Type: -

Identifier Source: org_study_id

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