LUNG INFECTION in ICU (LUNG-I3)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-05

Study Completion Date

2027-06-30

Brief Summary

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objective of LUNG-I3 study is to assess the quantitative and functional differences in cells between blood and bronchoalveolar lavage (BAL) fluid after an infection, with a special focus on alveolar macrophages and neutrophils

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Detailed Description

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Conditions

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VAP - Ventilator Associated Pneumonia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

All the following criteria

* Age 18 years or greater
* Severe ICU patients hospitalized for one of the above diseases:

* Septic shock (requirement of vasopressor to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol/L (\>18 mg/dL) in the absence of hypovolemia) caused either by pneumonia (n=20) or another source n=20)
* Severe trauma (level I and II), Injury Severity Score ≥ 25 OR
* Burn with TBSA over 20%
* NAD \> 0.1 µg/kg/min
* At least 2 SOFA criteria ≥ 2 points

Exclusion Criteria

* Aspiration pneumonia
* Unable to obtain a valid and written consent from a patient or their legally authorized representative in accordance with the local regulatory instances (this includes in FR: Person not affiliated to a health insurance scheme, or not a beneficiary of such a scheme. Persons who are the subject of a legal protection order. Person with restricted freedom following a legal or administrative decision and a person admitted without their consent pursuant to Articles L.3212-1 and 3213-1, which are not included in Article L.1121-8 of the French Public Health Code.)
* COPD
* Smoke inhalation in burn patients
* Participation in an intervention study
* Pregnant or breastfeeding women
* Immunocompromised patients, defined as

* patients with solid tumors with chemotherapy in the last 3 months or a progressive metastatic disease
* hematologic malignancies
* solid organ transplantation
* HIV infection with or without AIDS
* treatment with corticosteroids (\> 3 months at any dosage or ≥ 1 mg/kg prednisone equivalent per day for \> 7 day)
* treatment with other immunosuppressive drugs.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No