• Anesthesiology · Dec 2013

    Randomized Controlled Trial Multicenter Study Comparative Study

    Six Percent Hydroxyethyl Starch 130/0.4 (Voluven®) versus 5% Human Serum Albumin for Volume Replacement Therapy during Elective Open-heart Surgery in Pediatric Patients.

    • Philippe Van der Linden, Andrée De Villé, Anna Hofer, Martina Heschl, and Hans Gombotz.
    • * Professor, Department of Anesthesia, Centre hospitalier Universi taire Brugmann, Hôpital Universitaire des Enfants Reine Fabiola, Brussels, Belgium. † Staff Member, ‡ Professor, Department of Anesthesia and Intensive Care, Algemeines Krankenhaus der Stadt Linz, Linz, Austria.
    • Anesthesiology. 2013 Dec 1;119(6):1296-309.

    BackgroundAlthough 5% albumin (human serum albumin [HSA]) is widely used in cardiac surgery children, synthetic colloids may provide a valuable alternative. This study compared 6% hydroxyethyl starch (HES) 130/0.4 with HSA for volume replacement in this population.MethodsThe study was a two-center, randomized, controlled, parallel-group, double-blind trial performed in children aged 2-12 yr undergoing elective surgery for congenital heart disease under extracorporeal circulation. The primary objective was to demonstrate equivalence between HES and HSA with regard to the total volume of colloid infusion for intraoperative volume replacement including priming of the extracorporeal circuitery.ResultsIn the per-protocol population, mean volume of colloid required until end of surgery was (mean ± SD) 36.6 ± 11.8 ml/kg body weight in the HES group (N = 29) and 37.0 ± 11.9 ml/kg body weight in the HSA group (N = 26; ratio of means HES/HSA = 0.98 [95% CI, 0.84-1.16]). Intraoperative fluid balance was less positive in the HES group (P = 0.047). No difference was found regarding hemodynamics, the use of vasoactive and inotropic drugs. Blood loss, erythrocytes transfusion, and renal function were not different between groups. The incidence of adverse events up to postoperative day 28 did not differ between the groups.ConclusionsIn pediatric cardiac surgery, HES showed equivalence to HSA with regard to volume replacement therapy in children aged from 2 to 12 yr. Although there was no suggestion of an imbalance of safety measures between HES and HSA, the study was not powered to provide any firm conclusions about safety of tetrastarch in this population.

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