Laboratory Biomarkers and Pulmonary Interstitial Emphysema in ARDS (PIE-ARDS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversità Vita-Salute San Raffaele
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Patients with ARDS diagnosis will be enrolled. With the exception of blood and BAL samples collection, all patients enrolled in the prospective cohort will follow their normal course of diagnosis/treatment without any further requirements for the scope of this study other than those provided in the normal management of patients with this condition. Furthermore, any decision regarding drug or procedure will be made by the physician based on her/his clinical judgment, independently from the decision to include the patient in this study. No follow-up medical and/or imaging examinations/laboratory analysis after hospital discharge are needed by the present study design.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Blood and bronchoalveolar fluid collection and analysis
Diagnostic testBlood and bronchoalveolar lavage fluid will be collected within 12 hours after intubation. Blood samples will be centrifuged, and the serum immediately stored at less than 70° C. The following biomarkers will be analysed in the serum and bronchoalveolar lavage fluid: Interleukin-8 (IL-8), Interleukin (IL)-6, IL-1Ra, IL-18, interferon (IFN ), Angiopoietin-2 (Ang-2), Tumour Necrosis Factor receptor-1 (TNFr1), Plasminogen Activator Inhibitor-1(PAI-1), Receptor for Advanced Glycation Endproducts (RAGE), Intercellular adhesion molecule-1 (ICAM-1), Surfactant Protein D (SPD), protein C, Von Willebrand Factor (VWF), CXCL10/CXCR3, and metalloproteases (MMP9, MMP10). Blood samples obtained from the patients will be placed in specimen tubes containing heparin, centrifuged at 1500 G for 10 minutes, and then the plasma will be aspirated and stored at -70° C. Bronchoalveolar lavage fluid will be centrifuged at 1500 G for 10 minutes to remove cellular contents and stored at -70° C.
Chest CT scan
Diagnostic testComputed Tomography Scan per normal clinical practice
Treatment groups
110 Participants
are divided into 1 treatment groupGroup A: Acute Respiratory Distress Syndrome2 interventions
Trial outcomes
Primary outcomes
1
Rate of clinically relevant barotrauma
Barotrauma is diagnosed only in the case of clear radiological evidence (free air at chest X-ray and/or chest CT scan). Rate of barotrauma will be compared between patients with an hyperinflammatory pattern as compared with control.
Time frame
30 days or until hospital discharge. Specifically, from date of basal CT scan until the date of first radiologically documented barotraumaSponsors and contacts
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Source ClinicalTrials.gov