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Laboratory Biomarkers and Pulmonary Interstitial Emphysema in ARDS (PIE-ARDS)

Study acronym: PIE-ARDS
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Publications: 5 to 7v4
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2023 to Nov 27, 2023
    • Site details revised at 4 of 4 sites
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Barotrauma (pneumothorax, pneumomediastinum) is a well-described complication of Acute Respiratory Distress Syndrome (ARDS), especially in patients with coronavirus disease 2019 (COVID-19) (16.1% in COVID-19, and about 6% in non-COVID-19 ARDS). Macklin effect was recently discovered by our group as an accurate radiological predictor of barotrauma in COVID-19 ARDS; the Investigators also found that density histograms automatically extracted from chest CT images provide a reliable insight into lung composition . Since lung frailty is a major issue also in non-COVID-19 ARDS, the Investigators want to confirm the predictive role of Macklin effect also in this setting. In addition, the Investigators aim to explore inflammatory profiling to decipher different biological aspects of the same clinical issue. Finally, the Investigators want to develop a specific management algorithm for patients diagnosed, according to our findings, with a specific ARDS sub phenotype characterized by increased lung frailty
Trial Details
NCT Number NCT06001645
Lead Sponsor Università Vita-Salute San Raffaele
Conditions
(from sponsor)		 Acute Respiratory Distress Syndrome, Barotrauma
Related terms Barotrauma, Pneumothorax, Respiratory Distress Syndrome, Respiratory Insufficiency
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov