Acute Respiratory Distress SyndromeNCT03844893
Macrophage Programing in Acute Lung Injury
An observational study of Acute Respiratory Distress Syndrome, run by National Jewish Health.
Trial summary
The histologic hallmarks of lung inflammation and in the extreme, acute respiratory distress syndrome (ARDS), include intense accumulation of inflammatory cells in the airspaces and interstitium, injury to alveolar epithelial and endothelial cells, loss of epithelial-capillary integrity and accumulation of edema fluid… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Mini bal
- Type of treatment
- Surgery or procedure
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Mar 2023
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The population to be studied are patients identified to have ARDS, admitted to the intensive care unit, and placed on a mechanical ventilator. The MICU at National Jewish-St Joseph Hospital will be the primary site for enrollment. Control subjects will be individuals on mechanical ventilation for non-pulmonary reasons (i.e. following surgery, sepsis without lung involvement). A total of 56 subjects will be enrolled. As described below (in Research Methods and Enrollment) a 2:1 ratio of ARDS to control subjects will be targeted.
Who may be able to join
- Written, informed consent (by surrogate if unconscious or if altered mental status)
- Admission to a Medical Intensive care unit
- Orally/nasally intubated, evaluable within 24 h of intubation or onset of ARDS
- Expected to remain mechanically ventilated for at least 48 h after the first study procedure.
Who cannot join
- Treatment with immunosuppressants in the prior 3 months (antineoplastic agents, tumor necrosis factor alpha antagonists, cyclosporine, methotrexate, azathioprine, or mycophenolate. Treatment with glucocorticoids for septic shock is acceptable).
- History of solid organ or bone marrow transplantation
- History of chronic lung disease (e.g. COPD, pulmonary fibrosis, cystic fibrosis)
- Human immunodeficiency virus positivity
- Severe or massive hemoptysis
- At significant risk for bleeding (INR > 3 or PTT > 3x normal)
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- Presence of an advanced directive to withhold life-sustaining treatment
- Morbid state or expected to survive less than 14 days because of an advanced co-morbid medical condition;
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
The histologic hallmarks of lung inflammation and in the extreme, acute respiratory distress syndrome (ARDS), include intense accumulation of inflammatory cells in the airspaces and interstitium, injury to alveolar epithelial and endothelial cells, loss of epithelial-capillary integrity and accumulation of edema fluid in the interstitium and airspaces. Accordingly, for alveolar repair to occur inflammation must be halted, debris and inflammatory cells removed, injured tissue cells replaced, and capillary barrier function re-established. Macrophages are key players in all of these. Here the investigators hypothesize that resident alveolar macrophages and recruited macrophages serve completely different functions, acting independently (i.e. division of labor) yet cooperatively (synergism).
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Mini bal
- 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.
Mini balProcedure or surgery
Mini-BAL is a minimally invasive technique frequently used in the investigator's local intensive care units (ICUs) to obtain alveolar fluid samples from mechanically ventilated patients. This is typically done for microbial analysis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation and roles of macrophages during ARDS
Evaluation of resident alveolar macrophages will be distinguished with flow cytometry and enumerated
Measured: 10 days
Evaluation and roles of macrophages during ARDS
Evaluation of recruited alveolar macrophages will be isolated using FACS and subjected to RNA sequencing. Pro-inflammatory and pro-reparative modules will be assessed in the data set expression of transcription factors reported to drive macrophage polarization (HIF-1α, NF-kB, STAT-1, STAT-3, STAT-6, PPARγ, PU.1) will be assessed.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study startOct 2019 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844893
- Sponsor's protocol ID
- HS-3076
- Status last verified
- Feb 2019
- First submitted
- 12 Feb 2019
- Last updated
- 22 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macrophage Programing in Acute Lung Injury
- ClinicalTrials.gov ID
- NCT03844893
- Acronym / sponsor ID
- HS-3076
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 19 Feb 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.
The histologic hallmarks of lung inflammation and in the extreme, acute respiratory distress syndrome (ARDS), include intense accumulation of inflammatory cells in the airspaces and interstitium, injury to alveolar epithelial and endothelial cells, loss of epithelial-capillary integrity and accumulation of edema fluid in the interstitium and airspaces. Accordingly, for alveolar repair to occur inflammation must be halted, debris and inflammatory cells removed, injured tissue cells replaced, and capillary barrier function re-established. Macrophages are key players in all of these. Here the investigators hypothesize that resident alveolar macrophages and recruited macrophages serve completely different functions, acting independently (i.e. division of labor) yet cooperatively (synergism).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population to be studied are patients identified to have ARDS, admitted to the intensive care unit, and placed on a mechanical ventilator. The MICU at National Jewish-St Joseph Hospital will be the primary site for enrollment. Control subjects will be individuals on mechanical ventilation for non-pulmonary reasons (i.e. following surgery, sepsis without lung involvement). A total of 56 subjects will be enrolled. As described below (in Research Methods and Enrollment) a 2:1 ratio of ARDS to control subjects will be targeted.
Key inclusion criteria (4 listed)
- Written, informed consent (by surrogate if unconscious or if altered mental status)
- Admission to a Medical Intensive care unit
- Orally/nasally intubated, evaluable within 24 h of intubation or onset of ARDS
- Expected to remain mechanically ventilated for at least 48 h after the first study procedure.
Key exclusion criteria (9 listed)
- Treatment with immunosuppressants in the prior 3 months (antineoplastic agents, tumor necrosis factor alpha antagonists, cyclosporine, methotrexate, azathioprine, or mycophenolate. Treatment with glucocorticoids for septic shock is acceptable).
- History of solid organ or bone marrow transplantation
- History of chronic lung disease (e.g. COPD, pulmonary fibrosis, cystic fibrosis)
- Human immunodeficiency virus positivity
- Severe or massive hemoptysis
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 |
|---|---|---|
| Mini balMini-BAL is a minimally invasive technique frequently used in the investigator's local intensive care units (ICUs) to obtain alveolar fluid samples from mechanically ventilated patients. This is typically done for microbial analysis. | Procedure or surgery | – |
Primary outcome
Evaluation and roles of macrophages during ARDS
Time frame: 10 days
Evaluation of resident alveolar macrophages will be distinguished with flow cytometry and enumerated
Evaluation and roles of macrophages during ARDS
Time frame: 10 days
Evaluation of recruited alveolar macrophages will be isolated using FACS and subjected to RNA sequencing. Pro-inflammatory and pro-reparative modules will be assessed in the data set expression of transcription factors reported to drive macrophage polarization (HIF-1α, NF-kB, STAT-1, STAT-3, STAT-6, PPARγ, PU.1) will be assessed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by National Jewish Health.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine Griesmer, MPH (303-398-1325, griesmerc@njhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation and roles of macrophages during ARDS (time frame: 10 days). The study lists 2 primary outcomes in all. 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 Aug 2019.