ARDS, Human Clinical Trial
— BALARDSOfficial title:
Study of the Effects of Bronchoalveolar Lavage Liquid in the ARDS on the Functioning of the Neutrophil Polynuclear System
NCT number | NCT04008225 |
Other study ID # | 35RC15_9885 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 5, 2015 |
Est. completion date | May 5, 2016 |
Verified date | July 2019 |
Source | Rennes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 42 |
Est. completion date | May 5, 2016 |
Est. primary completion date | May 5, 2016 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
France | CHU de Rennes | Rennes |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lifespan of the PNNs | The lifespan of the PNNs is an indicator of apoptosis : two groups are compared with and without incubation in BAL fluid. Neutrophil necrosis was assessed by flow cytometry using a phycoerythrin-conjugated active caspase-3 apoptosis kit (Becton Dickinson, USA) |
24 hours after BAL | |
Secondary | PNNs phagocytic index | This index relates the ability of the PNNs to produce neutrophil extracellular traps (NETs). The release of NETs was quantified by measuring fluorescence with a microplate fluorescence reader (Varioskan, ThermoFisher Scientific, USA). |
24 hours after BAL | |
Secondary | Efferocytosis index | The efferocytosis index was determined on 300 cells as the percentage of Human monocyte-derived macrophages (HMDMs) containing at least one ingested apoptotic neutrophil. | 24 hours after BAL | |
Secondary | Increase of PNNs phagocytic index with HMGB1 activator | PNNs phagocytic index is measured after incubation with an anti-HMGB1 neutralising antibody | 24 hours after BAL | |
Secondary | Increase of Efferocytosis index metformin | efferocytosis index was determined after incubation with an AMP-activated protein kinase (AMPK) activator (metformin) | 24 hours after BAL |
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