Levosimendan in congenital cardiac surgery: a randomized, double-blind clinical trial.

Objective: In this study, the authors used a continuous infusion of either levosimendan or milrinone as inotropic support after corrective congenital cardiac surgery. The hemodynamic and biochemical parameters were compared.

Design: A prospective, randomized, double-blind clinical study.

Setting: A university hospital.

Participants: Forty-one patients between 0 and 5 years old requiring inotropic support for corrective congenital heart surgery under cardiopulmonary bypass (CPB) were enrolled in this trial. Thirty-six patients completed the study.

Interventions: Patients were randomized in a double-blind fashion to a continuous infusion of either levosimendan at 0.05 μg/kg/min or milrinone at 0.4 μg/kg/min started at the onset of CPB. Epinephrine was started at 0.02 μg/kg/min after aortic cross-clamp release in both groups.

Measurements And Main Results: There was no significant difference between serum lactate levels of groups. The rate-pressure index (the product of heart rate and systolic blood pressure), which is an indicator of myocardial oxygen demand, was significantly lower at 24 hours and 48 hours postoperatively in the levosimendan group (p < 0.001) in comparison to the milrinone group. Although not significantly different, the troponin values in the levosimendan group were less at 1 hour (median [P(25)-P(75)]: 20.7 [15.3- 48.3] v 34.6 [23.8- 64.5] ng/mL and 4 hours postoperatively: 30.4 [17.3-59.9] v 33.3 [25.5-76.7] ng/mL).

Conclusion: Levosimendan is at least as efficacious as milrinone after corrective congenital cardiac surgery in neonates and infants.