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:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-25 @ 4:24 AM
NCT ID:
NCT00850720
Eligibility Criteria:
Inclusion Criteria:
* Children with congenital heart disease requiring cardiopulmonary bypass(CPB) surgery less than 1 year of age admitted to the cardiac intensive care unit (CICU) preoperatively, who required blood sampling as part of their care.
* Subject must have arterial or central venous lines to be enrolled.
* Subject must have a documented weight of 2.5 Kilograms or greater.
* Subjects' legal guardian shall possess the ability to understand the purposes and risks of the study and provide an informed consent signature.
Exclusion Criteria:
* Medical urgency preventing timely administration of the consenting process.
* Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating. Specific conditions might include, but are not limited to, anemia or coagulopathy.
* Have given steroids intravenously (IV) or oral steroids within the last month.
* Have a preexisting neuroendocrine disorder.
* Have been treated with antipsychotic medication.
* Have human immunodeficiency virus (HIV).
* Have received etomidate for intubation.
* Other technical considerations that would prevent acquisition of sufficient samples OR inability / unwillingness of the legal guardian to provide consent.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
1 Year
Study:
NCT00850720
Study Brief:
Protocol Section:
NCT00850720