HES 130/0.4 (Voluven®) or human albumin in children younger than 2 yr undergoing non-cardiac surgery. A prospective, randomized, open label, multicentre trial

Abstract

For perioperative volume therapy in infants and young children, human albumin has frequently been the colloid of choice. Recently, HES 130/0.4 (6% hydroxyethyl starch, Voluven; Fresenius Kabi, Bad Homburg, Germany) was developed, which demonstrated improved pharmacokinetics and a favourable safety profile in adults compared with hydroxyethyl starch products with a less rapid metabolization. Our prospective, controlled, randomized, open, multicentre pilot study was designed to obtain data on the effects of HES 130/0.4 compared with human albumin 5% with regard to haemodynamics in children <2 yr scheduled for elective non-cardiac surgery. A total of 81 patients were treated. Comparable amounts of both study solutions (16.0 mL kg(-1) hydroxyethyl starch 130/0.4 vs. 16.9 mL kg(-1) human albumin 5%) as well as add-on crystalloids were used until 4-6 h postoperatively. No differences were detected between the two treatment groups regarding perioperative stabilization of haemodynamics, coagulation parameters, blood gas analyses or other laboratory values. Blood loss was 96 +/-143 mL for hydroxyethyl starch and 145+/- 290 mL for human albumin (P > 0.05). There were no relevant differences in the amount of red blood cells, fresh frozen plasma or platelet concentrates in both treatment groups. Median length of ICU stay was 3.5 days (range 1-57 days, mean +/- SD 7.6 +/- 11.5 days) in the hydroxyethyl starch group and 6.0 days (range 1-71 days; mean +/- SD 9.1 +/- 14.2 days) in the human albumin group. There was no difference for hospital stay (median: 12 days for both groups). Both HES 130/0.4 and human albumin 5% were effective for haemodynamic stabilization in non-cardiac surgery of young infants with no adverse impact on coagulation or other safety parameters in our study population.