Acute Respiratory Distress Syndrome (ARDS)IFRA2NCT01854424
Validation of the Percentage of Alveolar Fibrocyte as Biomarker During ARDS
An observational study of Acute Respiratory Distress Syndrome (ARDS) and Mechanical Ventilation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Fibrocyte is a monocyte sub-population involved in fibroproliferation/repair processes and associated with outcome in different diseases. In previous study, we have demonstrated the presence of alveolar fibrocytes during Acute expiratory Distress Syndrome (ARDS) and their association with patient outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS), Mechanical Ventilation
- What is being tested?
- Bronchoalveolar lavage (BAL) before day 2 , between days 5-7 and days 10-14 of evolution.
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to 11 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mechanically Ventilated patients after Sepsis, infectious pneumonia, trauma or postoperative complications.
Who may be able to join
- Ventilated patients with ARDS criteria as defined by Berlin criteria during the first 48 hours of evolution.
Who cannot join
- refusal of patient participation, pregnancy, HIV infection, Respiratory insufficiency, Pulmonary fibrosis, cirrhosis (> Child B score), scleroderma, Alzheimer's disease, Bone marrow transplant, chemotherapy-induced aplasia, immunosuppressive therapy, Corticosteroids (> 200 mg/day of hydrocortisone or equivalent in the two weeks preceding inclusion), End of life patient or IGS2 greater than 90, brain death, therapeutic limitation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Involvement of Fibrocytes in Repair Processes During Acute Respiratory Distress Syndrome (Validation Study-2)
Fibrocyte is a monocyte sub-population involved in fibroproliferation/repair processes and associated with outcome in different diseases. In previous study, we have demonstrated the presence of alveolar fibrocytes during Acute expiratory Distress Syndrome (ARDS) and their association with patient outcome. The purpose of this multicentric observational prospective study is to describe the percentage of alveolar fibrocytes in ICU patients with ARDS (survivors vs. non survivors) and to confirm their association with 28-day mortality.
Read the detailed description
Background: The acute respiratory distress syndrome (ARDS) remains common (15% of ventilated patients in the ICU), severe (30% of mortality) and have no specific treatment. Impaired epithelial repair with fibroproliferation is observed in non resolutive form of ARDS. Fibrocytes are cells that both express markers of hematopoietic cells (CD34+, CD45+) and fibroblasts (collagen-1). Fibrocytes may be recruited directly from the pool of circulating blood monocytes but also derive from monocytes in situ in absence of serum amyloid P (SAP or pentraxin-2). In murine models of lung injury, it has been shown that fibrocytes were recruited in the lung and contribute to the local fibrogenesis. Our team is the first to have demonstrated during ARDS in human the presence of fibrocytes among the alveolar cells obtained by bronchoalveolar lavage (BAL) (Quesnel et al, Eur Resp J, 2010). In a second single-center work enrolling 122 patients, we have shown that a percentage of alveolar fibrocytes > 6% was associated with an increased risk of death (HR = 6.2 [2.8 to 13.6], p <0.0001). However, this result remains to be confirmed in a second cohort because it was not the main objective of the first study and because of the variable lead time of BAL sampling in this cohort of patients with ARDS (Quesnel et al, CCM, 2012). Furthermore, the correlation of the percentage of blood fibrocytes (Fsg%) with the percentage of alveolar fibrocytes (Fal%) remains unknown and their kinetics remain to be studied during ARDS evolution.
Hypothesis and Objective: We hypothesize that percentage of alveolar fibrocytes is a prognostic marker during ARDS. Our main goal is to confirm in a validation cohort that the % of alveolar fibrocytes measured in BAL fluid during the first 48 hours of ARDS evolution is associated with 28-day mortality.
- Being tested
- Bronchoalveolar lavage (BAL) before day 2 , between days 5-7 and days 10-14 of evolution.
- Keywords
- Fibrocyte, Acute Respiratory Distress Syndrome, Serum Amyloid P, Fibrosis, Mortality
- Medical subject headings
- Respiratory Distress Syndrome, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoalveolar lavage (BAL) before day 2 , between days 5-7 and days 10-14 of evolution.Other
All the samples will be obtained during current care in the first week of evolution, and the last set of samples (BAL and blood sample between day 10-14) only in patients still under ventilation at this time point.
| Study group | Role | What they receive |
|---|---|---|
| ARDS | Ventilated patients with ARDS criteria (Berlin criteria) will be recruited in 3 ICU (2 from Bichat Hospital and 1 from Tenon Hospital, Paris) during the first 48 hours of their evolution. The patients will considered in 2 groups during analysis by taking into account their vital status at day-28 of inclusion. Receives: Other: Bronchoalveolar lavage (BAL) before day 2 , between days 5-7 and days 10-14 of evolution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the percentage of alveolar fibrocytes in survivors vs. non survivors during ARDS
Association with 28-day mortality after inclusion
Measured: alveolar fibrocytes percentage in BALF obtained in the 48 hours following ARDS diagnosis
Secondary outcomes (3)
To evaluate kinetics of alveolar and circulating fibrocytes between day-1 and day-14 of ARDS evolution
number of fibrocytes in BALF and blood samples
Measured: < day-2, day-3, day 5-7, day 10-14
To test the prognostic value of the percentage of alveolar fibrocytes during ARDS
Correlation between the percentage of alveolar or blood fibrocytes before day-2 and ventilation time (number of days without invasive ventilation between day 1 and day 28) and length of stay with organ failure (SOFA score evolution between day 1 and 28).
Measured: < day-2
To evaluate the association between the percentage of alveolar fibrocyte and inflammatory and fibroproliferative markers
association between % of alveolar fibrocytes and markers of epithelial injury and fibroproliferation (alveolar and serum IL-8, IL-10, sRAGE, TGF-beta, procollagen III, SAP, CCL18, concentrations) evaluated at day 1, 3, 5-7 and 10-14.
Measured: < day-2, day 5-7, day 10-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startNov 2013
- Primary completionJul 2016
- Study completion11 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe Quesnel, MD, PhD, Principal investigator, Assistance Publique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854424
- Sponsor's protocol ID
- NI11026
- Other IDs
- AOM 11005
- Acronym
- IFRA2
- Status last verified
- Mar 2017
- First submitted
- 13 May 2013
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involvement of Fibrocytes in Repair Processes During Acute Respiratory Distress Syndrome (Validation Study-2)
- ClinicalTrials.gov ID
- NCT01854424
- Acronym / sponsor ID
- IFRA2 / NI11026
- Keywords
- Fibrocyte, Acute Respiratory Distress Syndrome, Serum Amyloid P, Fibrosis, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Nov 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- 11 Jul 2016 (actual)
- First posted
- 15 May 2013 (estimated)
- 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.
Fibrocyte is a monocyte sub-population involved in fibroproliferation/repair processes and associated with outcome in different diseases. In previous study, we have demonstrated the presence of alveolar fibrocytes during Acute expiratory Distress Syndrome (ARDS) and their association with patient outcome. The purpose of this multicentric observational prospective study is to describe the percentage of alveolar fibrocytes in ICU patients with ARDS (survivors vs. non survivors) and to confirm their association with 28-day mortality.
Detailed description
Background: The acute respiratory distress syndrome (ARDS) remains common (15% of ventilated patients in the ICU), severe (30% of mortality) and have no specific treatment. Impaired epithelial repair with fibroproliferation is observed in non resolutive form of ARDS. Fibrocytes are cells that both express markers of hematopoietic cells (CD34+, CD45+) and fibroblasts (collagen-1). Fibrocytes may be recruited directly from the pool of circulating blood monocytes but also derive from monocytes in situ in absence of serum amyloid P (SAP or pentraxin-2). In murine models of lung injury, it has been shown that fibrocytes were recruited in the lung and contribute to the local fibrogenesis. Our team is the first to have demonstrated during ARDS in human the presence of fibrocytes among the alveolar cells obtained by bronchoalveolar lavage (BAL) (Quesnel et al, Eur Resp J, 2010). In a second single-center work enrolling 122 patients, we have shown that a percentage of alveolar fibrocytes > 6% was associated with an increased risk of death (HR = 6.2 [2.8 to 13.6], p <0.0001). However, this result remains to be confirmed in a second cohort because it was not the main objective of the first study and because of the variable lead time of BAL sampling in this cohort of patients with ARDS (Quesnel et al, CCM, 2012). Furthermore, the correlation of the percentage of blood fibrocytes (Fsg%) with the percentage of alveolar fibrocytes (Fal%) remains unknown and their kinetics remain to be studied during ARDS evolution.
Hypothesis and Objective: We hypothesize that percentage of alveolar fibrocytes is a prognostic marker during ARDS. Our main goal is to confirm in a validation cohort that the % of alveolar fibrocytes measured in BAL fluid during the first 48 hours of ARDS evolution is associated with 28-day mortality.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARDS | – | Other: Bronchoalveolar lavage (BAL) before day 2 , between days 5-7 and days 10-14 of evolution.Ventilated patients with ARDS criteria (Berlin criteria) will be recruited in 3 ICU (2 from Bichat Hospital and 1 from Tenon Hospital, Paris) during the first 48 hours of their evolution. The patients will considered in 2 groups during analysis by taking into account their vital status at day-28 of inclusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically Ventilated patients after Sepsis, infectious pneumonia, trauma or postoperative complications.
Key inclusion criteria (1 listed)
- Ventilated patients with ARDS criteria as defined by Berlin criteria during the first 48 hours of evolution.
Key exclusion criteria (1 listed)
- refusal of patient participation, pregnancy, HIV infection, Respiratory insufficiency, Pulmonary fibrosis, cirrhosis (> Child B score), scleroderma, Alzheimer's disease, Bone marrow transplant, chemotherapy-induced aplasia, immunosuppressive therapy, Corticosteroids (> 200 mg/day of hydrocortisone or equivalent in the two weeks preceding inclusion), End of life patient or IGS2 greater than 90, brain death, therapeutic limitation.
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 (BAL) before day 2 , between days 5-7 and days 10-14 of evolution.All the samples will be obtained during current care in the first week of evolution, and the last set of samples (BAL and blood sample between day 10-14) only in patients still under ventilation at this time point. | Other | ARDS |
Primary outcome
To determine the percentage of alveolar fibrocytes in survivors vs. non survivors during ARDS
Time frame: alveolar fibrocytes percentage in BALF obtained in the 48 hours following ARDS diagnosis
Association with 28-day mortality after inclusion
3 secondary outcomes
To evaluate kinetics of alveolar and circulating fibrocytes between day-1 and day-14 of ARDS evolution
Time frame: < day-2, day-3, day 5-7, day 10-14
To test the prognostic value of the percentage of alveolar fibrocytes during ARDS
Time frame: < day-2
To evaluate the association between the percentage of alveolar fibrocyte and inflammatory and fibroproliferative markers
Time frame: < day-2, day 5-7, day 10-14
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 22 Mar 2017.
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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.
Christophe Quesnel, MD, PhD principal investigator
Assistance Publique
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 Acute Respiratory Distress Syndrome (ARDS) and Mechanical Ventilation, run by Assistance Publique - Hôpitaux de Paris 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 1 inclusion and 1 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 22 Mar 2017. 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?
To determine the percentage of alveolar fibrocytes in survivors vs. non survivors during ARDS (time frame: alveolar fibrocytes percentage in BALF obtained in the 48 hours following ARDS diagnosis). 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 22 Mar 2017.