Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment110 (estimated)
SponsorUniversità Vita-Salute San Raffaele
Academic / other
Locations4 sites (Cagliari and 3 other locations)
StatusRecruiting
StartedNovember 27, 2023
Main results expectedApril 2027
Study endsJuly 2027
Registry record updatedAugust 12, 2025
Trial IDNCT06001645 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

  • 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.