RecruitingNCT07551258

Innate Immune Immunoparalysis and Ventilator-Associated Pneumonia in Critically Ill Elderly Patients

Intensity and Duration of Innate Immune System Immunoparalysis in the Pathophysiology of Ventilator-Associated Pneumonia in Mechanically Ventilated Elderly Patients


Sponsor

Hospital Universitari de Bellvitge

Enrollment

170 participants

Start Date

May 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

This prospective observational cohort study aims to evaluate the role of innate immune immunoparalysis in the development of ventilator-associated pneumonia (VAP) in critically ill mechanically ventilated patients. Immunoparalysis will be assessed through monocyte HLA-DR expression and ex vivo lipopolysaccharide (LPS)-stimulated TNF-α production. The study will include three cohorts: elderly patients (≥65 years), younger adults (\<65 years), and healthy controls. The primary objective is to determine whether the presence, duration, intensity, and trend of immunoparalysis are associated with the incidence of VAP and other ICU-acquired infections. Secondary objectives include characterization of immunoparalysis dynamics, comparison of measurement methods, and evaluation of clinical outcomes.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • ≥18 years
  • Mechanical ventilation expected >48h
  • Intubation between 24h pre- and 48h post- ICU admission
  • Informed consent

Exclusion Criteria5

  • Known severe immunosuppression, including primary immunodeficiency disorders, advanced HIV infection (AIDS), active hematological malignancy under treatment, recent chemotherapy or immunosuppressive therapy
  • High dose steroids at immunosuppressive doses
  • Active autoimmune disease
  • Pregnancy
  • End-of-life situation

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Locations(1)

Servei de medicina intensiva, Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

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NCT07551258


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