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

ConditionsRespiratory Distress Syndrome (RDS)Respiratory Failure

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity of Padova

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

ARDS DIAGNOSIS

IMV

Disqualifiers

Age under 18 years

Pregnancy status

Lack of consent to participate in the study

Contraindications to fiberoptic bronchoscopy and/or BAL (bronchoalveolar lavage)

Trial population

Adult patients affected by ARDS and requiring IMV

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

40 Participants

are grouped into 2 trial groups

Group A: CASES

Group B: CONTROLS

Trial outcomes

Primary outcomes

SERPINB3

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

Time frame

Within 72 hours from ARDS diagnosis

SCCA-PD

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

Time frame

Within 72 hours from ARDS diagnosis

Secondary outcomes

FIBROSIS and SERPINB3, PAR2, SCCA-PD variant

Investigating potential correlations between the Ichikado score (calculated on the CTscan performed after 21±7 days from ARDS diagnosis) and the expression of SERPINB3, PAR2 and the SCCA-PD variant.

Time frame

At 21 days from ARDS diagnosis

60-DAY MORTALITY PREDICITVE MODELS

Subsequently, identifying new models able to predict 60-day mortality according to anthropometric, clinical, respiratory parameters and laboratory data of lung damage (i.e., SERPINB3, PAR2, inflammatory cytokines (including TNF-a, TGF-ß ect) and cytofluorimetric measurements).

Time frame

At 60-day after ARDS diagnosis

Other outcomes

Only if available

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

Time frame

At 21 days after ARDS diagnosis

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Padova

Lead sponsor

Source ClinicalTrials.gov

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