Macrophage Programing in Acute Lung Injury

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Macrophage Programing in Acute Lung Injury

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03844893
• Other study ID #: HS-3076
• Status: Not yet recruiting
• Start date: October 2019
• Est. completion date: March 2023

Study information

• Verified date: February 2019
• Source: National Jewish Health
• Contact: Christine Griesmer, MPH
• Phone: 303-398-1325
• Email: griesmerc[@]njhealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Procedure:
• Mini 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Jewish Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation and roles of macrophages during ARDS	Evaluation of resident alveolar macrophages will be distinguished with flow cytometry and enumerated	10 days
Primary	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-1a, NF-kB, STAT-1, STAT-3, STAT-6, PPAR?, PU.1) will be assessed.	10 days