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Recruiting
NCT05795257
Pulmonary Immune Cell-microbiome Interactions in ARDS
Conditions: ARDS, Human
Sex: All
Ages: 18 Years – N/A
Enrollment: 40
Sponsor: Hvidovre University Hospital
Location: Hvidovre Hospital, University of Copenhagen Hvidovre
Summary
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.
Eligibility 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
Source: ClinicalTrials.gov (NCT05795257). StuddyBuddy aggregates publicly available trial information.