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 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT02044159
Eligibility Criteria:
Inclusion Criteria:
* Children newborn to 17 years
* On any dose of any vasoactive infusion for between 1 to 6 hours
Exclusion Criteria:
* Patients who have known or suspected hypothalamic, pituitary or adrenal disease
* Patients who are currently receiving steroids for the treatment of shock/suspected shock prior to randomization
* Patients who are expected to have treatment withdrawn
* Patients who are premature infants (\<38 weeks corrected gestational age)
* Patients who are pregnant
* Patients post cardiac surgery
* Patient who received their first dose of vasoactive infusion \>24 hours after PICU admission
* Patient who is no longer on vasoactive infusion at the time of study enrollment, and/or is expected to no longer be on vasoactive infusion at the time the first dose of study drug will be administered
* Patients for whom primary cardiogenic shock is strongly suspected
* Patients for whom spinal shock is strongly suspected
* Patients for whom hemorrhagic or hypovolemic shock is strongly suspected
* Patients who were previously enrolled in the STRIPES study
* Patients who receive a vasoactive agent for reasons not related to shock
* Physician refusal
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
17 Years
Study:
NCT02044159
Study Brief:
Protocol Section:
NCT02044159