Pulmonary Immune Cell-microbiome Interactions in ARDS
Recruiting now
Conditions studied: ARDS, Human
In brief
The overall aim is to compare the composition and spatial heterogeneity of the following in critically ill intensive care unit (ICU) patients: i) immune cell populations and their activation patterns, ii) the surrounding cytokine-chemokine milieu, including trans-compartmental fluxes of these mediators between the lung and bloodstream, and iii) the lung microbiome. Main hypotheses: * The immune cell population in bronchoalveolar lavage fluid (BALF) from patients with ARDS is dominated by neutrocytes, while T cells are depleted, and show evidence of hyper-activation and exhaustion * T cell hyper-activation and exhaustion is specifically compartmentalised to the lungs, and much more pronounced in moderate-to-severe than none-to-mild ARDS * Cyto- and chemokines derived from pulmonary immune cells are higher in moderate-to-severe than none-to-mild ARDS with a greater release from lungs to the bloodstream, notably of IL-6 and IL-8. * The differences in T cell profile in BALF, notably the ratio between regulatory T cells and T helper 17 cells, will change with disease severity over time, and can be explained by the presence of tI-IFN antibodies and/or a low microbial diversity of the respiratory tract with low enrichment from the oral cavity.
Key facts
- Study ID
- NCT05795257
- Run by
- Hvidovre University Hospital
- People needed
- 40
- Starts
- 2023-03-14
- Expected to finish
- 2028-11-30
- Last updated by the study team
- 2025-03-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Hvidovre Hospital, University of Copenhagen — Hvidovre, Denmark (enrolling)
Full record on ClinicalTrials.gov
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