Investigating immune cell and microbiome interactions in ARDS patients
Pulmonary Immune Cell-microbiome Interactions in Acute Respiratory Distress Syndrome: the ILLUMINA-1 Study
This study looks at how immune cells and gut bacteria interact in critically ill patients with acute respiratory distress syndrome (ARDS) to see if these factors affect how serious their condition is.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hvidovre University Hospital Academic / other |
| Locations | 1 site (Hvidovre) |
| Trial ID | NCT05795257 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the immune cell populations and their activation patterns, the cytokine-chemokine environment, and the lung microbiome in critically ill ICU patients with acute respiratory distress syndrome (ARDS). It will involve collecting bronchoalveolar lavage fluid and blood samples from patients categorized into none-to-mild and moderate-to-severe ARDS groups. The study seeks to understand how these factors relate to disease severity and progression, particularly focusing on T cell behavior and the microbiome's role in ARDS. Data will be collected within 72 hours of intubation and again after 7-10 days if the patient remains intubated.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are intubated within 72 hours and diagnosed with either moderate-to-severe or none-to-mild ARDS.
Not a fit: Patients with ARDS caused by COVID-19 or those with contraindications for bronchoscopy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of ARDS, potentially enhancing patient outcomes.
How similar studies have performed: While the specific interactions between immune cells and the microbiome in ARDS have not been extensively studied, related research in other conditions has shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inclusion criteria - moderate-to-severe ARDS * Admitted to the ICU at Hvidovre Hospital * Intubated within the past 72 hours * Moderate-to-severe ARDS according to the Berlin definition19 * Age ≥ 18 years Inclusion criteria - none-to-mild ARDS * Admitted to the ICU at Hvidovre Hospital * Intubated within the past 72 hours * None-to-mild ARDS according to the Berlin definition19 * Age ≥ 18 years Exclusion Criteria: * ARDS caused by COVID-19 * Absolute contraindications for bronchoscopy * Untreated malignant arrhythmia * Documented or suspected intracranial hypertension (intracranial pressure ≥ \> 15 mmHg) * One-lung ventilation * Severe coagulopathy
Where this trial is running
Hvidovre
- Hvidovre Hospital, University of Copenhagen — Hvidovre, Denmark (Recruiting)
Study contacts
- Study coordinator: MD, PhD, Ronni Plovsing
- Email: ronni.thermann.reitz.plovsing.01@regionh.dk
- Phone: +45386220721
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.