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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT02046135
Eligibility Criteria:
Inclusion Criteria:
1. Subjects age ≤18 years
2. Subjects scheduled for cardiac surgery with cardiopulmonary bypass
Exclusion Criteria:
1. Subjects with abnormal creatinine clearance (\<90 ml/min/1.7m2) as measured by the Schwartz formula
2. Subjects with known cystic kidney disease or posterior ureteral valves (subjects with solitary kidney, single multicystic/dysplastic kidney, hydronephrosis will not be excluded if renal function is preserved)
3. Subjects with known metabolic disorder
4. Premature infants born \<30 weeks gestation and \<30 days old due to risk of intraventricular hemorrhage
Subjects in severe cardiogenic shock post-operative requiring extra-corporeal membrane oxygenation (ECMO) or left ventricular assist device (LVAD) will be withdrawn from the study.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT02046135
Study Brief:
Protocol Section:
NCT02046135