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:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT06915506
Eligibility Criteria:
Inclusion Criteria
* Age ≥ 18 years.
* Diagnosis of sepsis or septic shock in the acute phase, as defined by the -Sepsis-3 criteria (confirmed infection with Sequential Organ Failure Assessment \[SOFA\] score ≥ 2 points above baseline).
* Voluntary participation with written informed consent provided by the patient or legally authorized representative.
Exclusion Criteria
* Severe carotid atherosclerosis (e.g., carotid Intima-Media Thickness (IMT)\>1.2 mm or confirmed plaque formation) diagnosed by prior imaging.
* Significant cardiovascular comorbidities that may confound hemodynamic assessments, including:
* Severe cardiomyopathy (e.g., ejection fraction \<30%).
* Uncontrolled arrhythmias (e.g., ventricular tachycardia, atrial fibrillation with rapid ventricular response).
* Congenital heart disease with hemodynamic instability.
* Active hepatic or renal insufficiency (e.g., Child-Pugh class C, dialysis dependence) or advanced systemic diseases (e.g., metastatic malignancy, terminal illness).
* Poor ultrasound image quality precluding reliable speckle tracking analysis (e.g., inadequate acoustic window, motion artifacts).
* Pregnancy or lactation (due to potential hormonal influences on vascular physiology).
* Withdrawal from the study or inability to complete follow-up assessments (e.g., non-compliance, transfer to another facility).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06915506
Study Brief:
Protocol Section:
NCT06915506