Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID06774534

The ASSESSMENT of SERPINB3 Expression, PAR2, and SCCA-PD Polymorphism in Patients with Acute Respiratory Distress Syndrome

Led by University of Padova · Updated on 2025-03-05

40

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying Acute Respiratory Distress Syndrome (ARDS), a severe lung condition that causes respiratory failure, inflammation, and tissue damage, often leading to high mortality. The study focuses on understanding the roles of SERPINB3, PAR2, and the SCCA-PD polymorphism in ARDS patients. These molecules are believed to contribute to lung injury and fibrosis, but their involvement in ARDS patients has not been previously confirmed. This research aims to identify patient subgroups at higher risk and support the development of targeted treatments. The study will observe two groups: patients with ARDS requiring invasive mechanical ventilation and control patients in intensive care needing ventilation for reasons other than respiratory failure. Data collected include clinical, ventilatory, and biomolecular information. Participants will have high-resolution chest CT scans within 72 hours of ARDS diagnosis and again around 21 days later or at hospital discharge. Blood and bronchoalveolar lavage samples will be collected within 72 hours and, if possible, at 21 days to analyze SERPINB3, PAR2, and SCCA-PD expression and their association with lung fibrosis. During the study, researchers will monitor the progression of lung fibrosis using imaging and biomarker analysis. They will assess SERPINB3 and SCCA-PD levels shortly after diagnosis and evaluate fibrosis and mortality risk models at later time points. Data collection will continue until hospital discharge. The study uses leftover clinical samples for research and tracks outcomes including 60-day mortality. Overall participation duration varies with hospital stay and follow-up timing.

CONDITIONS

Brief Title

SerpinB3 Expression, PAR2 and SCCA-PD Polymorphism in Acute Respiratory Distress Syndrome

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Acute Respiratory Distress Syndrome (ARDS)
  • Receiving invasive mechanical ventilation (IMV)
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Pregnancy
  • No consent to participate in the study
  • Contraindications to fiberoptic bronchoscopy or bronchoalveolar lavage (BAL)
  • Chronic inflammatory skin conditions
  • Chronic lung diseases
  • Inflammatory respiratory diseases
  • Certain cancers including squamous cell carcinoma of cervix or esophagus, lung adenocarcinoma, breast adenocarcinoma, pancreatic adenocarcinoma, hepatocellular carcinoma
  • History of active or passive smoking

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Within 72 hours of ARDS diagnosis

Participants undergo high-resolution chest CT scans within 72 hours of ARDS diagnosis to assess lung fibrosis and provide blood and bronchoalveolar lavage samples as part of routine clinical care for research.

1 visit (in-person)

Long-term Monitoring

Duration - 21 ± 7 days after ARDS diagnosis or until hospital discharge

Participants are monitored with a second high-resolution chest CT scan and potential additional blood and bronchoalveolar lavage samples at 21 ± 7 days after ARDS diagnosis or at hospital discharge to evaluate progression of lung changes and fibrosis.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 60 days after ARDS diagnosis

Participants are observed for clinical outcomes including 60-day mortality following ARDS diagnosis with data collected according to institutional protocols.

Data collection during routine clinical care; no additional visits required

Trial Site Locations

Total: 1 location

1

Azienda Ospedaliera di Padova

Padova, PD, Italy, 35126

Actively Recruiting

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Research Team

A

Annalisa Boscolo, Professor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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