CClinicalTrials.gg
Status unknownNCT03844893Updated Aug 22, 2019

Macrophage Programing in Acute Lung Injury

An observational study in Acute Respiratory Distress Syndrome, sponsored by National Jewish Health. Status unknown. Per ClinicalTrials.gov, last updated 2019-08-22.

Sponsored by National Jewish Health · Observational

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
56
Sex
All
01

Study 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 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).

02

Conditions studied

03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's planned enrollment of 56 is below the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

National Jewish Health is the lead sponsor of 108 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  1. Written, informed consent (by surrogate if unconscious or if altered mental status)
  2. Admission to a Medical Intensive care unit
  3. Orally/nasally intubated, evaluable within 24 h of intubation or onset of ARDS
  4. Expected to remain mechanically ventilated for at least 48 h after the first study procedure.

Exclusion criteria

Exclusion Criteria:

  1. 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).
  2. History of solid organ or bone marrow transplantation
  3. History of chronic lung disease (e.g. COPD, pulmonary fibrosis, cystic fibrosis)
  4. Human immunodeficiency virus positivity
  5. Severe or massive hemoptysis
  6. At significant risk for bleeding (INR > 3 or PTT > 3x normal)
  7. Presence of an advanced directive to withhold life-sustaining treatment
  8. Morbid state or expected to survive less than 14 days because of an advanced co-morbid medical condition;
  9. Pregnancy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
56 participants (estimated)
Patient registry
No

Interventions

  • ProcedureMini bal

    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.

06

What researchers measure

Primary outcomes

  1. Evaluation and roles of macrophages during ARDS

    Evaluation of resident alveolar macrophages will be distinguished with flow cytometry and enumerated

    Time frame: 10 days

  2. 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.

    Time frame: 10 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03844893
Lead sponsor
National Jewish Health
Responsible party
Sponsor
First posted
Feb 19, 2019
Start date
Oct 2019 (estimated)
Primary completion
Mar 2023 (estimated)
Completion
Mar 2023 (estimated)
Last update
Aug 22, 2019

Study contacts

Christine Griesmer, MPH
Contact
griesmerc@njhealth.org
303-398-1325

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion