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 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT03025659
Eligibility Criteria:
Inclusion Criteria:
* All immediately post-operative cardiac patients admitted to the pediatric cardiac intensive care unit (PCICU)
Exclusion Criteria:
* Lack of parental or patient consent, or patient assent when applicable, including non-English speakers and wards of the state
* Dosing weight less than 4 kg\*
* Cardiac catheterization being the only operative procedure
* Severe hepatic dysfunction at any time during the hospital course
* Seizures during the study period
* Sepsis during the study period
* Need for extracorporeal membrane oxygenation or continuous renal replacement therapy
* Known congenital myopathy, ataxia, polyneuropathies or inborn errors of metabolism including congenital lactic acidosis and other mitochondrial disorders
* Primary hypoventilation
* Malignancies
* Fanconi syndrome
* Wernicke encephalopathy
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT03025659
Study Brief:
Protocol Section:
NCT03025659