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

Abstract

Background: Although 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. Methods: The 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. Results: In 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. Conclusions: In 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.

Speaker Abstracts

“…These latter results were confirmed in a meta-analysis (Martin, Jacob et al, 2013). These two formal analyses are in accordance with the results of two prospective randomized controlled studies performed in children undergoing cardiac surgery, that reported the equivalence of tetrastarches compared to human albumin for perioperative fluid replacement, without any increase in the incidence of postoperative complications (Hanart, Khalife et al, 2009;Van der Linden, De Ville et al, 2013). In these studies, the tetrastarch was associated with a decreased fluid balance, which could have a significant impact on postoperative morbidity and mortality (Hassinger, Wald et al, 2014).…”

Plasma fibrinogen concentration is correlated with postoperative blood loss in children undergoing cardiac surgery

“…From a clinical point of view, it should be noted that, in our population, the use of 6% HES 130/0.4 has not been associated with significantly higher perioperative blood loss or other side effects when compared with 4 or 5% albumin. 34,35 In addition, the association between HES 130/0.4 administration and increased perioperative blood loss has recently been contradicted in a review of the literature. 36 In the present study, although the volume of HES 130/0.4 used was higher in the 'bleeders' than in the 'nonbleeders', the volume of HES 130/0.4 was not found to be a predictive factor of postoperative bleeding in multivariate logistic regression analysis.…”

AKI after pediatric cardiac surgery for congenital heart diseases–recent developments in diagnostic criteria and early diagnosis by biomarkers-

“…HES and 5% albumin were used for intraoperative volume replacement including priming of the extracorporeal circuitry. Urinary renal biomarkers (α1-microglobulin, β-N-acetylglucosaminidase, NGAL, and albumin) increased in all patients after surgery but without significant differences between the HES group and 5% albumin group [54]. Van Der Linden et al also showed in a retrospective propensity-matched study that the effectiveness of 6% HES 130/0.4 was equal to that of 4% albumin for kidney injury in 1495 cardiac surgery children with CPB [55].…”