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 @ 4:59 PM
Ignite Modification Date:
2025-12-24 @ 4:59 PM
NCT ID:
NCT00848250
Eligibility Criteria:
Inclusion Criteria:
* Infants or children (newborn to 17 years of age) undergoing cardiopulmonary bypass for elective surgical correction of a congenital heart defect.
* Patients must be taking an ACE inhibitor prior to their operation
Exclusion Criteria:
* Patients in which discontinuing ACEIs is deemed unsafe by their primary cardiologist
* Any condition rendering the subjects legal guardian unable to understand the nature, scope, and possible consequences of the study.
* Pregnancy as ruled out by standard of care screening procedures.
* Individuals whose weight is less than 3.5 kg at the time of enrollment.
* Inability to comply with the protocol. ie. Children in whom it is deemed unsafe to have the extra blood draws, and children who are thought to be noncompliant with their medications.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
17 Years
Study:
NCT00848250
Study Brief:
Protocol Section:
NCT00848250