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 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT05336357
Eligibility Criteria:
Inclusion Criteria
* Age \> 18 years;
* Patients admitted to Emergency Units, Intensive Care Units, and Wards within 3 hours of the diagnosis of Septic Shock:
* Systolic Blood Pressure (SBP) \< 90 mmHg and/or Mean Arterial Pressure (MAP) \< 65 mmHg (with or without norepinephrine at a dose less than 0.5 mcg/kg/min) + Clinical signs of infection and at least one of the following:
* Lactate \> 2 mEq/L;
* Oliguria (urine output \< 0.5 mL/kg/h for at least 6 hours);
* Neurological changes (mental confusion, decreased level of consciousness, psychomotor agitation, temporal-spatial disorientation);
* Capillary refill time \> 3 s (after digital compression for 10 seconds);
* Poor skin perfusion.
* Signed Informed Consent Form.
Exclusion Criteria
* Hospital admission time greater than 24 hours
* Significant edema in the fingers
* Severe peripheral vasoconstriction
* Use of Norepinephrine at a dose greater than or equal to 0.5 mcg/kg/min
* Presence of significant Aortic Insufficiency
* Patients undergoing Renal Replacement Therapy
* Patients with ST-segment elevation Myocardial Infarction
* Patients requiring Invasive Mechanical Ventilation
* Patients already participating in another study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05336357
Study Brief:
Protocol Section:
NCT05336357