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 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
NCT ID:
NCT00628550
Eligibility Criteria:
Inclusion Criteria:
* All children, ages 0 to 18 years, admitted to the PICU who experience CPA requiring either chest compressions and/or defibrillation. This will include males, females and Spanish speaking individuals.
* Patients must require at least 2 doses of vasopressor medication during the CPA event (all patients would receive epinephrine as first dose, followed by either epinephrine or vasopressin as second dose depending on randomization, all subsequent doses required would be epinephrine) given via any route (intravenous, intraosseous, or endotracheal).
Exclusion Criteria:
* Do Not Attempt Resuscitate (DNAR) patients
* Chemical code only (i.e., no CPR/defibrillation)
* Events not requiring chest compressions and/or defibrillation
* Events with a pulse requiring synchronized or unsynchronized cardioversion
* Successful internal cardiac device defibrillation of Vfib/pVT that initiates the resuscitation event
* Defibrillation for Vfib/pVT without administration of a vasopressor
* All patients in the custody of the State of Texas
* Any patient whose parent or guardian "opts out" of the study
* Any patient who is pregnant
* Any patient whose attending physician "opts out" of the study
* Any patient who does not consent to follow up data collection
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT00628550
Study Brief:
Protocol Section:
NCT00628550