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Mini Bronchoalveolar Lavage for Lung Injury
N/A
Recruiting
Research Sponsored by WilliamJanssen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days on ventilator 1-2, 4-6 and 8-10
Awards & highlights
No Placebo-Only Group
Summary
This trial will look at how white blood cells respond to lung inflammation in people with ARDS and how testing lung cells can help reduce the time to start treatment for ventilator-associated pneumonia. Participants will receive oxygen, have small amounts of fluid taken from their lungs, and have nasal and blood samples taken.
Who is the study for?
This trial is for ICU patients on mechanical ventilation due to ARDS or similar conditions, expected to remain ventilated for at least 48 hours. It's not suitable for those with chronic lung diseases, recent immunosuppressant use, history of organ transplant, severe bleeding risks, a directive against life-sustaining treatment, morbid state with less than 14 days survival expectancy or pregnancy.
What is being tested?
The study observes how white blood cells in the lungs respond to inflammation from ARDS. Participants undergo non-bronchoscopic mini bronchoalveolar lavage (miniBAL) where saline is introduced and then removed from the lungs via a catheter for analysis. This helps understand immune responses and may expedite pneumonia treatment initiation.
What are the potential side effects?
Potential side effects include discomfort during the miniBAL procedure and risks associated with pre-oxygenation and fluid introduction into the lungs such as temporary oxygen level changes. Blood draws might cause bruising or infection at the needle site.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days on ventilator 1-2, 4-6 and 8-10
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days on ventilator 1-2, 4-6 and 8-10
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluate host response to ARDS
Macrophage signaling
Recruited versus resident macrophages
+1 moreSecondary study objectives
Ventilator associated pneumonia (VAP)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Study Population GroupExperimental Treatment1 Intervention
People in the ICU on mechanical ventilation due to a diagnosis of ARDS or any other diagnosis that requires mechanical ventilation (following surgery, sepsis without lung involvement, seizures)
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Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,944 Previous Clinical Trials
47,799,773 Total Patients Enrolled
WilliamJanssenLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a solid organ or bone marrow transplant.I have had severe or massive coughing up of blood.I have given, or my legal representative has given, written consent for the study.I am between 18 and 85 years old.I have been admitted to the intensive care unit.I am currently intubated or will be within the next 48 hours.
Research Study Groups:
This trial has the following groups:- Group 1: Study Population Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.