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

NCT06774534 | Recruiting DMC

• 1 other identifier: AOP3543
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The Acute Respiratory Distress Syndrome (ARDS) is a systemic syndrome characterized by severe respiratory failure, inflammation, loss of aerated tissue and high mortality. Recently, significant efforts have been made to phenotype ARDS patients through a wide range of new biomarkers and imaging indices with the goal of developing personalized treatments based on patient's biophenotypization. Recent literature demonstrates, both in vitro and in vivo but not yet in ARDS patients, that the serine protease inhibitor(SERPIN)-B3 plays a crucial role in the pathological mechanism of pulmonary fibrogenesis, and, similarly, protease-activated receptors(PAR2) is highly involved in this aberrant inflammatory response. Consequently, studying the expression of SERPINB3 (including SCCA-PD polymorphism) and PAR2, in association with a detailed clinical and biomolecular phenotypization, could allow new insights into the pathophysiological mechanisms of lung injury during ARDS.

Conditions

Respiratory Distress Syndrome (RDS); Respiratory Failure

Keywords

ARDS; RESPIRATORY FAILURE; ICU

Outcome Measures

Primary Outcomes (2)

• SERPINB3

  Quantifying the expression of SERPINB3, PAR2 (measured in blood, bronchoalveolare lavage (BAL), and extracellular vesicles (EV)) in adult ARDS patients, requiring ventilatory support.

  Within 72 hours from ARDS diagnosis

• SCCA-PD

  Quantifying the occurrence of SCCA-PD variant in adult ARDS patients, requiring ventilatory support.

  Within 72 hours from ARDS diagnosis

Secondary Outcomes (2)

• FIBROSIS and SERPINB3, PAR2, SCCA-PD variant

  At 21 days from ARDS diagnosis

• 60-DAY MORTALITY PREDICITVE MODELS

  At 60-day after ARDS diagnosis

Other Outcomes (1)

• Only if available

  At 21 days after ARDS diagnosis

Study Arms (2)

CASES

Patients affected by Acute Respiratory Distress Syndrome (ARDS) and needing invasive mechanical ventilation (IMV).

CONTROLS

Patients admitted to the Intensive Care Unit and requiring IMV not for respiratory reasons.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients affected by ARDS and requiring IMV

You may qualify if:

• ARDS DIAGNOSIS
• IMV

You may not qualify if:

• Age under 18 years
• Pregnancy status
• Lack of consent to participate in the study
• Contraindications to fiberoptic bronchoscopy and/or BAL (bronchoalveolar lavage)
• Patients with chronic inflammatory skin conditions
• Patients with chronic lung diseases
• Patients with inflammatory respiratory diseases
• Patients with neoplasms such as: squamous cell carcinoma of the cervix, squamous cell carcinoma of the esophagus, lung adenocarcinoma, breast adenocarcinoma, pancreatic adenocarcinoma, hepatocellular carcinoma
• History of active or passive smoking

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Azienda Ospedaliera di Padova

Padua, PD, 35126, Italy

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Annalisa Boscolo, Professor

CONTACT

+393498324972; annalisa.boscolo@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 14, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 5, 2025

Record last verified: 2025-02

Locations

IT (1)