Last updated: April 11, 2022
Sponsor: Le Bonheur Children's Hospital
Overall Status: Active - Recruiting
Phase
3
Condition
Kidney Disease
Renal Failure
Kidney Failure
Treatment
N/AClinical Study ID
NCT03897335
Acute Kidney Injury
Ages < 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Cohort 1
- All children undergoing open heart surgery for congenital heart defects with orwithout circulatory arrest
- Neonates (<28 days old) and infants (<1 years of age)
- Hypoplastic L heart syndrome or its variants.
- Coarctation with aortic arch hypoplasia.
- Interrupted aortic arch.
- TAPVR (Total anomalous pulmonary venous return)
- Patients with complex congenital heart defects Cohort 2:
- Orthotopic heart transplantation patients.
- Patients ≤ 18 years of age
- Congenital heart defects
- Cardiomyopathy (Dilated/Hypertrophic/Restrictive/Left Ventricular Non-compaction)
Exclusion
Exclusion Criteria:
- Children under the age of 12 months undergoing bypass for any condition that is notcategorized as congenital heart defect
- History of seizures
- History of significant tachyarrhythmia.
Study Design
Total Participants: 80
Study Start date:
February 07, 2019
Estimated Completion Date:
February 01, 2024
Study Description
Connect with a study center
LeBonheur Children's Hospital
Memphis, Tennessee 38103
United StatesActive - Recruiting
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