NCT05767671 Macrophage Programing in Acute Lung Injury: MiniBAL
| NCT ID | NCT05767671 |
| Status | Recruiting |
| Phase | — |
| Sponsor | William Janssen, MD |
| Condition | Acute Respiratory Distress Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2020-04-10 |
| Primary Completion | 2027-09-18 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 56 participants in total. It began in 2020-04-10 with a primary completion date of 2027-09-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational clinical trial is to learn about the role white blood cells (macrophages) play in lung inflammation in people with Acute Respiratory Distress Syndrome (ARDS). The main questions it aims to answer are: 1. How does the immune system respond to different kinds of lung injury and inflammation and how do those processes differ from each other? 2. What roles do the cells that live in the lungs (macrophages) play in turning off inflammation? How does their role differ from other cells that are called to the lung to help repair injury (recruited macrophages)? 3. Will more frequent testing of lung cell samples help reduce the time it takes to start treatment for ventilator-associated pneumonia (VAP) and therefore reduce the rates of initial therapy failure? Participants will be in the intensive care unit (ICU) on a mechanical ventilator (machine that helps patients breathe) because they have ARDS or are on a mechanical ventilator for some other reason (control group). The following will happen: 1. Participants will be given 100% oxygen through the breathing machine (mechanical ventilator) for 3-5 minutes. This is called pre-oxygenation. 2. A lung specialist (pulmonologist), a member of Dr. Janssen's research team, or respiratory therapist will place small amount of saline into the lung using a long catheter going through the breathing tube. 3. The fluid will be removed with suction and will be sent to the laboratory for testing. 4. This will be repeated two more times over the course of 10 days, or less if participants are taken off of the ventilator. The procedure will be performed no more than three times. 5. Two nasal brushings will be taken from the participants' nose. 6. Approximately 3 tablespoons of blood will be removed by putting a needle into the participants vein. This is the standard method used to obtain blood for tests. A total of 9 tablespoons will be taken for research purposes over the course of this study 7. Data including the participants age, sex, severity of illness, and other medical conditions will be recorded to determine how these can affect the white blood cells. 8. If bacteria are isolated from the fluid in the participants lung, the participants' physician may choose to place the participants on antibiotics to treat an infection. 9. A follow-up phone call may be made by a member of the research team after discharge from the hospital. At this time, the participant may be invited to participate in the Post-ICU clinic at National Jewish Health.
Eligibility Criteria
Inclusion Criteria: * Written informed consent (by LAR if subject unconscious or has altered mental status) prior to any study procedures. Verbal consent may be used as necessary * Adults greater than 18 years of age * Admission to the intensive care unit. * Orally/nasally intubated or expected to be intubated within 48 hours Exclusion Criteria: * History of solid organ or bone marrow transplantation * Severe or massive hemoptysis * At significant risk for bleeding (INR \> 3 or PTT \> 3x normal) * Presence of pneumomediastinum or pneumothorax on recent imaging * Presence of an advanced directive with Do Not Intubate (DNI) status (Do Not Resuscitate (DNR) is acceptable) * Morbid state or expected to survive less than 24 hours because of an advanced co-morbid medical condition in the opinion of the PI and/or clinical team and attending physician. * Pregnancy
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05767671 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Acute Respiratory Distress Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05767671 currently recruiting?
Yes, NCT05767671 is actively recruiting participants. Contact the research team at verburgo@njhealth.org for enrollment information.
Where is the NCT05767671 trial being conducted?
This trial is being conducted at Denver, United States.
Who is sponsoring the NCT05767671 clinical trial?
NCT05767671 is sponsored by William Janssen, MD. The trial plans to enroll 56 participants.