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

NCT07551258 | Not Yet Recruiting

• 1 other identifier: IMP-VM
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Immunoparalysis; Intubated ICU Patients; Ventilator Associated Pneumonia ( VAP)

Keywords

invasive mechanical ventilation; LPS stimulation; HLA-DR; innate immunity; ICU-acquired infections

Outcome Measures

Primary Outcomes (1)

• Incidence of ventilator-associated pneumonia (VAP)

  Occurrence of ventilator-associated pneumonia in critically ill mechanically ventilated patients, defined according to standard clinical, radiological, and microbiological criteria.

  Up to 28 days after intubation

Secondary Outcomes (10)

• Incidence of ICU-acquired infections

  Up to 28 days after intubation

• Duration of invasive mechanical ventilation

  Up to 28 Days after intubation

• All-cause mortality at 28 days

  28 days after intubation

• Evolution of Sequential Organ Failure Assessment (SOFA) score

  From ICU admission to day 15 or ICU discharge, whichever occurs first.

• Prevalence of innate immune immunoparalysis at ICU admission

  At ICU admission (baseline)

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill adult patients requiring invasive mechanical ventilation for more than 48 hours and admitted to the Intensive Care Unit will be consecutively screened for inclusion. The study will include two patient cohorts (≥65 years and 18-64 years), as well as a cohort of healthy adult volunteers serving as controls.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Servei de medicina intensiva, Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples (plasma) will be stored for the assessment of immunological parameters. Although plasma may contain cell-free DNA (cfDNA) and mitochondrial DNA (mtDNA), no genetic analyses are planned in this study.

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: April 24, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 28, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

ES (1)