The cohort of children was prospectively enrolled from 3 pediatric sites: Cincinnati Children’s Hospital Medical Center, Montreal Children’s Hospital, and Yale New-Haven Children's Hospital as part of the consortium investigating new biomarkers in AKI known as the Translational Research Investigating Biomarker Endpoints in Acute Kidney Injury (TRIBE-AKI). Enrollment started in July 2007, November 2007, and November 2008, respectively, and completed in December 2009. Cincinnati has a dedicated pediatric cardiac care unit (CCU) with approximately 225 cardiopulmonary bypass cases annually and both Montreal and Yale have mixed medical surgical units including cardiac patients with approximately 60 cardiopulmonary bypass cases annually. This study was approved by the Institutional Review Board or Research Ethics Board of each institution. Written informed consent from legal guardians and assent from patients were obtained before enrollment.
All patients less than 18 years of age undergoing cardiac surgery with cardiopulmonary bypass were eligible for the study. Exclusion criteria included history of prior renal transplantation, dialysis requirement, or participation in a conflicting research study. We utilized the Risk Adjustment for Congenital Heart Surgery 1 (RACHS-1) consensus-based scoring system to categorize the complexity of surgery (24 (link)). This method of risk stratification is a widely accepted tool for the evaluation of differences in outcomes of surgery for congenital heart disease. We only retained children older than 1 month for this study, since defining AKI in neonates is unclear and likely different than the AKI definition in older children (25 (link)).
All patients less than 18 years of age undergoing cardiac surgery with cardiopulmonary bypass were eligible for the study. Exclusion criteria included history of prior renal transplantation, dialysis requirement, or participation in a conflicting research study. We utilized the Risk Adjustment for Congenital Heart Surgery 1 (RACHS-1) consensus-based scoring system to categorize the complexity of surgery (24 (link)). This method of risk stratification is a widely accepted tool for the evaluation of differences in outcomes of surgery for congenital heart disease. We only retained children older than 1 month for this study, since defining AKI in neonates is unclear and likely different than the AKI definition in older children (25 (link)).
