Exploring biomarkers and lung damage in ARDS patients
Official title: Pulmonary Interstitial Emphysema (Macklin Effect), Quantitative Imaging Analysis and CytoKine Profiling to Predict Lung Frailty IN ARDS
Run by Università Vita-Salute San Raffaele · NCT06001645 · Data updated 2026-11-12
This study is trying to see if certain signs in the lungs and blood can help identify ARDS patients, especially those with COVID-19, who are at risk of lung damage from treatment, so that doctors can better manage their care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Università Vita-Salute San Raffaele Academic / other |
| Locations | 4 sites (Cagliari and 3 other locations) |
| Status | Recruiting |
| Started | November 27, 2023 |
| Main results expected | April 2027 |
| Study ends | July 2027 |
| Registry record updated | August 12, 2025 |
| Trial ID | NCT06001645 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients diagnosed with ARDS who meet the Berlin criteria and require ICU admission.
✕Probably not a fit
Patients with poor quality imaging due to motion or respiratory artifacts may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the occurrence of barotrauma in patients with Acute Respiratory Distress Syndrome (ARDS), particularly focusing on those with COVID-19. It aims to validate the Macklin effect as a predictor of barotrauma and to analyze inflammatory profiles through blood and bronchoalveolar fluid collection. The study will also utilize chest CT scans to assess lung composition and develop a management algorithm tailored for ARDS patients at high risk of barotrauma. By identifying high-risk features early, the study seeks to improve individualized patient management.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for ARDS patients, potentially reducing the incidence of barotrauma and associated mortality.
How similar studies have gone: While the Macklin effect has been identified in COVID-19 ARDS, this study aims to confirm its predictive role in non-COVID-19 ARDS, making it a novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical and radiological signs of ARDS, according to Berlin criteria, requiring ICU admission; * Obtain duly signed informed consent * Availability of at least one chest CT scan during hospital stay Exclusion Criteria: • Poor quality imaging (because of motion/respiratory artefacts).
Where it's running
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IRCCS San Raffaele Scientific Institute
Milan, Italy Recruiting -
A.O.U. di Cagliari
Cagliari, Italy Not yet recruiting -
A.O.U. Pisana
Pisa, Italy Not yet recruiting -
Ospedale San Carlo
Potenza, Italy Not yet recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.