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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• ≥18 years

• Mechanical ventilation expected \>48h

• Intubation between 24h pre- and 48h post- ICU admission

• Informed consent

Locations
Other Locations
Spain
Servei de medicina intensiva, Hospital Universitari de Bellvitge
RECRUITING
L'hospitalet De Llobregat
Time Frame
Start Date: 2026-05-01
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 170
Treatments
Elderly Mechanically Ventilated Patients (≥65 years)
Critically ill patients aged 65 years or older requiring invasive mechanical ventilation for more than 48 hours. This is the primary study cohort in which innate immune immunoparalysis will be assessed and its association with ventilator-associated pneumonia will be analyzed.
Adult Mechanically Ventilated Patients (<65 years)
Critically ill patients aged 18 to 64 years requiring invasive mechanical ventilation for more than 48 hours, included as a comparison cohort to evaluate age-related differences in immunoparalysis.
Healthy Non-Intubated Controls
Healthy adult volunteers without acute illness and not requiring mechanical ventilation. This group, assessed at a single time point, will serve as a reference population for baseline immunological parameters.
Related Therapeutic Areas
Sponsors
Leads: Hospital Universitari de Bellvitge

This content was sourced from clinicaltrials.gov