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 @ 7:40 PM
Ignite Modification Date:
2025-12-24 @ 7:40 PM
NCT ID:
NCT06062303
Eligibility Criteria:
Inclusion Criteria:
* Consecutive adult patients (≥ 18 years)
* Patients with septic shock according to Sepsis-3 consensus conference. In short, septic shock is defined as suspected or confirmed infection, plus hyperlactatemia and NE requirements due to persistent hypotension, after a fluid load of at least 1000mL in 1h
* Patient and/or relative informed and having signed the information and consent form for participation in the study
Exclusion Criteria:
* More than 4 hours since septic shock diagnosis,
* Anticipated surgery or acute hemodialysis procedure to start during the 6h intervention period
* Active bleeding,
* Do not resuscitate status,
* Child B-C Cirrhosis
* Underlying disease process with a life expectancy \< 90 days and/or the attending clinician deems aggressive resuscitation unsuitable
* Refractory shock (high risk of death within 24h)
* Pregnancy
* Concomitant severe acute respiratory distress syndrome
* Patients in whom CRT cannot be accurately assessed
* Non-affiliation to a social security scheme or to another social protection scheme
* Patient on AME (state medical aid) (unless exemption from affiliation
* Patient under legal protection (guardianship, curatorship)
* Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants, if applicable
* Inability, according to the investigator, to understand the study (non-French-speaking patient, cognitive disorders)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06062303
Study Brief:
Protocol Section:
NCT06062303