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:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT05039151
Eligibility Criteria:
Inclusion Criteria:
COMMON INCLUSION CRITERIA
* Patient under mechanical ventilation and sedation
* Patient and/or trusted person (health care proxy) or close relative who has given their oral consent after being informed,
* Age ≥ 18 years old,
INCLUSION CRITERIA FOR THE SEPTIC SHOCK GROUP
* Diagnosis within 24 hours of admission of septic shock as defined by :
* A probable or confirmed infection
* And a SOFA score ≥ 2
* And the need to introduce vasopressors to obtain a MAP ≥ 65 mmHg despite adequate vascular filling
* And an arterial lactate \> 2 mmol/l
* Norepinephrine dose greater than 0.1 μg/kg/min
* Septic shock present for less than 48 hours
INCLUSION CRITERIA FOR THE CONTROL GROUP
\- Absence of sepsis and shock from any cause within 2 months prior to inclusion
Exclusion Criteria:
* Disseminated intravascular coagulation (DIC) with haemorrhagic syndrome
* Acute condition that can mimic sepsis :
* Acute pancreatitis without signs of superinfection
* Metformin Intoxication
* Patient with an unfavourable prognosis within 24 hours
* Patient under legal protection (safeguard of justice, guardianship or tutelage)
* Pregnant or breastfeeding women
* Patient not affiliated to national health insurance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05039151
Study Brief:
Protocol Section:
NCT05039151