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Immunity Markers in Intensive Care Patients and Ventilator-associated Pneumonia

ConditionPneumonia, Ventilator-Associated
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Intercommunal Aix-Pertuis

About this trial

The goal of this observational study is to show the direct correlation between the occurrence of recurrence of VAP and postagressive immunoparalysis, monitored by HLA-DR rate below litterature-acknowledged threshold, in a well conducted antibiotherapy context, in patient admitted in the Intensive Care Unit.

The main questions it aims to answer are:

* evaluation of the association between death and persistence of immunoplegia using HLA-DR monitoring * search an association between immunoplegia depth and severity of the initial state of shock * search an association between immunoplegia depth and viral reactivation * compare association of immunoplegia duration and HLA-DR nadir and VAP occurrence Blood samples will be taken from participants to HLA-DR dosage, at the time of inclusion and once a week then.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient over 18 years old

Patient admitted in the Intensive Care Unit of the CHIAP

Patient under mechanical ventilation

Patient with infectious pneumonia

Disqualifiers

Patient under 18 years old

Patient with severe neutropenia (neutrophils < 0.5 G/L)

Patient under immunosuppressive treatment

Use of corticosteroids (intravenous or oral) prior to ICU admission

Trial population

Patient admitted in the ICU of the CHIAP under mechanical ventilation and with infectious pneumonia

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood collection

    Diagnostic test

    HLA-DR dosage, at the time of inclusion and once a week then

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Interventional - blood collection1 intervention

Trial outcomes

Primary outcomes

1

Occurrence of a VAP recurrence/relapse

Number of occurrence of a VAP recurrence/relapse

Time frame
From date of hospital admission until the date of the end of hospitalization or date of death from any cause, whichever came first, assessed up to 100 months

Secondary outcomes

1

Viral reactivation

To search for association between immunoplegia depth and viral reactivation (CMV)

Time frame
From date of hospital admission until the date of the end of hospitalization or date of death from any cause, whichever came first, assessed up to 100 months
2

Association between immunoparalysis depth and state of shock severity within the first 24 hours

To search for association between immunoplegia depth and severity of the initial state of shock (lactatemia, amine dosage, SOFA score over 48 hours)

Time frame
First 24 hours
3

Persistence of immunoparalysis during hospitalization and care-related infections

To compare association of immunoplegia duration and HLA-DR nadir and VAP occurrence

Time frame
From date of hospital admission until the date of the end of hospitalization or date of death from any cause, whichever came first, assessed up to 100 months
4

HLA-DR nadir and link with care-related infections

To compare association of immunoplegia duration and HLA-DR nadir and VAP occurrence

Time frame
From date of hospital admission until the date of the end of hospitalization or date of death from any cause, whichever came first, assessed up to 100 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Intercommunal Aix-Pertuis

Lead sponsor

Source ClinicalTrials.gov
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