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Clinical Trials in Spain / NCT07551258
Recruiting Observational

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

NCT07551258 · tracked via the Priya Life Science Spain tracker
Sponsor
Hospital Universitari de Bellvitge
Phase
Observational
Started
2026-05-01
Last updated
2026-05-19

Condition(s) studied

Intubated ICU PatientsVentilator Associated Pneumonia ( VAP)Immunoparalysis

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * ≥18 years * Mechanical ventilation expected \>48h * Intubation between 24h pre- and 48h post- ICU admission * Informed consent Exclusion Criteria: * 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

Primary outcome measure(s)

  • Incidence of ventilator-associated pneumonia (VAP) — Up to 28 days after intubation
    Occurrence of ventilator-associated pneumonia in critically ill mechanically ventilated patients, defined according to standard clinical, radiological, and microbiological criteria.

Trial sites (1)

FacilityCityRegionStatus
Servei de medicina intensiva, Hospital Universitari de Bellvitge L'Hospitalet de Llobregat Barcelona Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07551258 on ClinicalTrials.gov ↗ ← All trials in Spain