Background: Aprotinin is a potent antifibrinolytic drug, which reduces postoperative bleeding and transfusion requirements. Recently, two observational studies reported increased incidence of renal dysfunction after aprotinin use in adults. Therefore, the aim of the study was to investigate the safety of aprotinin use in pediatric cardiac surgery patients.
Methods: Data were prospectively and consecutively collected from 657 pediatric patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). The database was assessed with regard to a possible relationship between aprotinin administration and dialysis and between aprotinin and postoperative renal dysfunction [defined as 25% decrease in the creatinine clearance (Ccr) compared with the preoperative value] by propensity-score adjustment and multivariable methods.
Results: The incidence of dialysis (9.6% vs 4.1%; P = 0.005) and renal dysfunction (26.3% vs 16.1%; P = 0.019) was higher in patients who received aprotinin; however, propensity adjusted risk ratios were not significant [odds ratio (OR) of dialysis: 1.22; 95% confidence interval (CI) 0.46-3.22; OR of renal dysfunction 1.26; 95% CI: 0.66-1.92]. Aprotinin significantly reduced blood loss in the first postoperative 24 h. The main contributors of renal dysfunction were CPB duration, cumulative inotropic support, age, preoperative Ccr, amount of transfusion and pulmonary hypertension.
Conclusions: Despite the higher incidences of renal dysfunction and failure in the aprotinin group, an independent role of the drug in the development of renal dysfunction or dialysis could not be demonstrated in pediatric cardiac patients undergoing CPB.