Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Macrophage Programing in Acute Lung Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03844893
Recruitment Status : Not yet recruiting
First Posted : February 19, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
National Jewish Health

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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).

Condition or disease Intervention/treatment
Acute Respiratory Distress Syndrome Procedure: Mini bal

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Macrophage Programing in Acute Lung Injury
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • 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.

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Evaluation and roles of macrophages during ARDS [ Time Frame: 10 days ]
    Evaluation of resident alveolar macrophages will be distinguished with flow cytometry and enumerated

  2. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844893


Contacts
Layout table for location contacts
Contact: Christine Griesmer, MPH 303-398-1325 griesmerc@njhealth.org

Sponsors and Collaborators
National Jewish Health
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: National Jewish Health
ClinicalTrials.gov Identifier: NCT03844893    
Other Study ID Numbers: HS-3076
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries