• Pediatr Crit Care Me · Oct 2019

    Randomized Controlled Trial Multicenter Study

    The Effect of Levosimendan Versus Milrinone on the Occurrence Rate of Acute Kidney Injury Following Congenital Heart Surgery in Infants: A Randomized Clinical Trial.

    • Elin M Thorlacius, Pertti K Suominen, Håkan Wåhlander, Juho Keski-Nisula, Maria Vistnes, Sven-Erik Ricksten, Mats Synnergren, Birgitta S Romlin, and Albert Castellheim.
    • Department of Anesthesiology and Intensive Care Medicine, Sahlgrenska Academy, University of Gothenburg and Queen Silvia Children's Hospital, Sahlgrenska University Hospital, Gothenburg, Sweden.
    • Pediatr Crit Care Me. 2019 Oct 1; 20 (10): 947-956.

    ObjectivesIt has been shown that, in contrast to other inotropic agents, levosimendan improves glomerular filtration rate after adult cardiac surgery. The aim of this study was to investigate the efficacy of levosimendan, compared with milrinone, in preventing acute kidney dysfunction in infants after open-heart surgery with cardiopulmonary bypass.DesignTwo-center, double-blinded, prospective, randomized clinical trial.SettingThe study was performed in two tertiary pediatric centers, one in Sweden (Gothenburg) and one in Finland (Helsinki).PatientsInfants between 1 and 12 months old, diagnosed with Tetralogy of Fallot, complete atrioventricular septal defect or nonrestrictive ventricular septal defect, undergoing total corrective cardiac surgery with cardiopulmonary bypass.InterventionsSeventy-two infants were randomized to receive a perioperative infusion of levosimendan (0.1 µg/kg/min) or milrinone (0.4 µg/kg/min). The infusion was initiated at the start of cardiopulmonary bypass and continued for 26 hours.Measurements And Main ResultsThe primary outcome variable was the absolute value of serum creatinine data on postoperative day 1. Secondary outcomes included the following: 1) acute kidney injury according to the serum creatinine criteria of the Kidney Diseases: Improving Global Outcomes; 2) acute kidney injury with serum creatinine corrected for fluid balance; 3) plasma neutrophil gelatinase-associated lipocalin; 4) cystatin C; 5) urea; 6) lactate; 7) hemodynamic variables; 8) use of diuretics in the PICU; 9) need of dialysis; 10) length of ventilator therapy; and 11) length of PICU stays. There was no significant difference in postoperative serum creatinine between the treatment groups over time (p = 0.65). The occurrence rate of acute kidney injury within 48 hours was 46.9% in the levosimendan group and 39.5% in the milrinone group (p = 0.70). There were no significant differences in other secondary outcome variables between the groups.ConclusionsLevosimendan compared with milrinone did not reduce the occurrence rate of acute kidney injury in infants after total corrective heart surgery for atrioventricular septal defect, ventricular septal defect, or Tetralogy of Fallot.

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