NCT05795257 Pulmonary Immune Cell-microbiome Interactions in ARDS
| NCT ID | NCT05795257 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hvidovre University Hospital |
| Condition | ARDS, Human |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-03-14 |
| Primary Completion | 2028-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2023-03-14 with a primary completion date of 2028-11-30.
⚠ 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 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
Contact & Investigator
MD PhD Ronan berg
STUDY CHAIR
Biomedical Science of Health, University of Copenhagen
Frequently Asked Questions
Who can join the NCT05795257 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ARDS, Human. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05795257 currently recruiting?
Yes, NCT05795257 is actively recruiting participants. Contact the research team at ronni.thermann.reitz.plovsing.01@regionh.dk for enrollment information.
Where is the NCT05795257 trial being conducted?
This trial is being conducted at Hvidovre, Denmark.
Who is sponsoring the NCT05795257 clinical trial?
NCT05795257 is sponsored by Hvidovre University Hospital. The principal investigator is MD PhD Ronan berg at Biomedical Science of Health, University of Copenhagen. The trial plans to enroll 40 participants.