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Recruiting NCT07551258

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

— Observational Intubated ICU Patients Ventilator Associated Pneumonia ( VAP) Immunoparalysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Intubated ICU Patients, Ventilator Associated Pneumonia ( VAP), Immunoparalysis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Incidence of ventilator-associated pneumonia (VAP) [Time frame: Up to 28 days after intubation]
Secondary outcome measures (10)
  • Incidence of ICU-acquired infections [Time frame: Up to 28 days after intubation]
  • Duration of invasive mechanical ventilation [Time frame: Up to 28 Days after intubation]
  • All-cause mortality at 28 days [Time frame: 28 days after intubation]
  • Evolution of Sequential Organ Failure Assessment (SOFA) score [Time frame: From ICU admission to day 15 or ICU discharge, whichever occurs first.]
  • Prevalence of innate immune immunoparalysis at ICU admission [Time frame: At ICU admission (baseline)]
  • Temporal evolution of innate immune immunoparalysis [Time frame: Baseline, 24 hours, day 3, and day 5 after intubation]
  • Agreement between HLA-DR expression and LPS-stimulated TNF-α production [Time frame: From baseline to day 5 after intubation.]
  • Identification of immunoparalysis thresholds associated with clinical outcomes [Time frame: Up to 28 days after intubation.]
  • Correlation between immunoparalysis and clinical outcomes [Time frame: From ICU admission to day 90, depending on the clinical outcome assessed]
  • Effect of macrolide therapy on immunoparalysis and infection outcomes [Time frame: Up to 28 days after intubation.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Servei de medicina intensiva, Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat

Identifiers

NCT: NCT07551258 · IMP-VM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗