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

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.

NCT Number	NCT07551258
Lead Sponsor	Hospital Universitari de Bellvitge
Conditions	Intubated ICU Patients, Ventilator Associated Pneumonia ( VAP), Immunoparalysis
Enrollment	170 participants
Start Date	2026-05-01
Primary Completion	2028-05-28 (estimated)
Study Completion	2028-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-19