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 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT01449669
Eligibility Criteria:
Inclusion Criteria:
* Males or females with single ventricle physiology undergoing their second palliation procedure (typically performed between 3-6 months of age)
* Use of cefazolin as the prophylactic antibiotic during the operation
* Written informed consent provided by the parent or legal guardian
Exclusion Criteria:
* Use of prophylactic antibiotic other than cefazolin during the operation
* Anatomic or other abnormalities of the upper arm that would preclude insertion of a microdialysis catheter
* Known renal or hepatic function
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
6 Months
Study:
NCT01449669
Study Brief:
Protocol Section:
NCT01449669