Molecular Endotype-Specific Dynamics of Lung Endothelial Barrier Integrity in Sepsis

Recruiting

• Conditions: Septic Shock; Pneumonia; Sepsis

• Registration Number: NCT06287684
• Lead Sponsor: Mater Dei Hospital, Malta

Brief Summary

Sepsis is a complex syndrome that causes lethal organ dysfunction due to an abnormal host response to infection. No drug specifically targeting sepsis has been approved. The heterogeneity in sepsis pathophysiology hinders the identification of patients who would benefit, or be harmed, from specific therapeutic interventions. Recent clinical genomics studies have shown that sepsis patients can be stratified as molecular endotypes, or subclasses, with important clinical implications. Classifying sepsis patients as molecular endotypes revealed that a poor prognosis endotype was characterized by immunosuppression and septic shock. Against this backdrop, the study hypothesis is that a poor prognosis for sepsis is defined by a molecular endotype reflecting impaired innate immune and endothelial barrier integrity in the primary anatomical site of infection.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-13
• Status Verified: 2024-02
• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-02-29
• Last Update Submitted: 2024-02-29
• Study First Posted: 2024-03-01
• Last Update Posted: 2024-03-01
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Age ≥ 18 years
• Acute respiratory tract infection due to community- or hospital-acquired pneumonia

Exclusion Criteria

• Consent card not signed
• Pregnancy
• Prisoners
• Aspiration pneumonitis
• Patients with ventilator-associated pneumonia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient stratification as transcriptomic endotypes	Through study completion, an average of 1 year	Molecular endotype classification of sepsis patients secondary to pneumonia
Lung endothelial barrier integrity	Through study completion, an average of 1 year	Measurement of soluble mediators of endothelial function in bronchoalveolar lavage

Secondary Outcome Measures

Name	Time	Method
Survival	2 years	Assessment of survival

Trial Locations

Locations (1)

Mater Dei hospital, Intensive Care Unit; 🇲🇹 Imsida, Malta