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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT03731104
Eligibility Criteria:
Inclusion Criteria:
Neonates and children from 0 to 18 years old hospitalized in pediatric intensive care unit (PICU) with hemodynamic failure requiring vasoactive or inotropic treatment. This includes :
* shock (tachycardia, troubles of peripheral perfusion with capillary refill time \>3 sec, oliguria, with or without alteration of consciousness or arterial hypotension)
* isolated arterial hypotension if it needs medical treatment to readjust balance between oxygen demand and oxygen consumption
Exclusion Criteria:
* primitive cerebral lesion: traumatic or neurosurgical (including brain death states)
* preterm neonates of less than 37 weeks gestational age
* patients already receiving more than one catecholamine
* patients too instable, defined by a respiratory instability (pulse oxymetry of less than 80% during more than 5 minutes) and/or hemodynamic instability (variability of blood pressure and heart rate of more than 50%) and/or cardiorespiratory arrest.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
18 Years
Study:
NCT03731104
Study Brief:
Protocol Section:
NCT03731104