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 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT06793020
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older;
* Sepsis according to SEPSIS-3 criteria:
* Suspected/confirmed infection and
* SOFA (Sequential Organ Failure Assessment) score ≥ 2 or qSOFA score ≥ 2;
* Septic shock according to SEPSIS-3 criteria:
* Sepsis is diagnosed and
* Vasopressor infusion is used to maintain a mean arterial pressure (MAP) ≥ 65 mmHg and
* Lactate \> 2 mmol/l;
* Cardiovascular support requirement for norepinephrine \> 0.1 mcg/kg/min infusion;
* Signed informed consent form (ICF);
Exclusion Criteria:
* Individuals under 18 years of age;
* Has uncompensated cardiovascular disease:
* Cardiogenic shock;
* Congenital heart disease;
* Heart failure NYHA functional class IV;
* Refusal to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06793020
Study Brief:
Protocol Section:
NCT06793020