ARDS, HumanBALARDSNCT04008225
Study of the Effects of Bronchoalveolar Lavage Liquid in the ARDS on the Functioning of the Neutrophil Polynuclear System
An observational study of ARDS, Human, run by Rennes University Hospital at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ARDS, Human
- What is being tested?
- Bronchoalveolar lavage
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2015to 5 May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
Study population: * 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%.
Who may be able to join
- 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%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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
- ARDS, Human
- Being tested
- Bronchoalveolar lavage
- Keywords
- Bronchoalveolar lavage
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoalveolar lavageProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Bronchoalveolar lavage | |
| 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%. Receives: Procedure: Bronchoalveolar lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 hours after BAL
Secondary outcomes (4)
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).
Measured: 24 hours after BAL
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.
Measured: 24 hours after BAL
Increase of PNNs phagocytic index with HMGB1 activator
PNNs phagocytic index is measured after incubation with an anti-HMGB1 neutralising antibody
Measured: 24 hours after BAL
Increase of Efferocytosis index metformin
efferocytosis index was determined after incubation with an AMP-activated protein kinase (AMPK) activator (metformin)
Measured: 24 hours after BAL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start5 May 2015
- Primary completion5 May 2016
- Study completion5 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS, HumanStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marc TADIE, MD, PhD, Principal investigator, University Hospital of Rennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008225
- Sponsor's protocol ID
- 35RC15_9885
- Acronym
- BALARDS
- Status last verified
- Jul 2019
- First submitted
- 2 Jul 2019
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Bronchoalveolar Lavage Liquid in the ARDS on the Functioning of the Neutrophil Polynuclear System
- ClinicalTrials.gov ID
- NCT04008225
- Acronym / sponsor ID
- BALARDS / 35RC15_9885
- Conditions
- ARDS, Human
- Keywords
- Bronchoalveolar lavage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 5 May 2015 (actual)
- Primary completion
- 5 May 2016 (actual)
- Study completion
- 5 May 2016 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARDS group | – | Procedure: Bronchoalveolar lavageInpatients 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. |
| Control group | – | Procedure: Bronchoalveolar lavageThe 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%. |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- * 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%.
Key inclusion criteria (2 listed)
- 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%.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoalveolar lavage | Procedure or surgery | ARDS group, Control group |
Primary outcome
Lifespan of the PNNs
Time frame: 24 hours after BAL
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)
4 secondary outcomes
PNNs phagocytic index
Time frame: 24 hours after BAL
Efferocytosis index
Time frame: 24 hours after BAL
Increase of PNNs phagocytic index with HMGB1 activator
Time frame: 24 hours after BAL
Increase of Efferocytosis index metformin
Time frame: 24 hours after BAL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Marc TADIE, MD, PhD principal investigator
University Hospital of Rennes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS, Human, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lifespan of the PNNs (time frame: 24 hours after BAL). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019.