Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT06073834
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06073834
Study Brief:
Protocol Section:
NCT06073834