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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.
Eur J Anaesthesiol. 2008 Jun; 25(6):437-45.EJ

Abstract

BACKGROUND AND OBJECTIVE

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.

METHODS

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.

RESULTS

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).

CONCLUSIONS

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.

Authors+Show Affiliations

Academic Hospital Solingen, Department of Anesthesia and Critical Care Medicine, Solingen, Hannover, Germany. standl@klinikumsolingen.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18339212

Citation

Standl, T, et al. "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." European Journal of Anaesthesiology, vol. 25, no. 6, 2008, pp. 437-45.
Standl T, Lochbuehler H, Galli C, et al. 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. Eur J Anaesthesiol. 2008;25(6):437-45.
Standl, T., Lochbuehler, H., Galli, C., Reich, A., Dietrich, G., & Hagemann, H. (2008). 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. European Journal of Anaesthesiology, 25(6), 437-45. https://doi.org/10.1017/S0265021508003888
Standl T, et al. 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. Eur J Anaesthesiol. 2008;25(6):437-45. PubMed PMID: 18339212.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Standl,T, AU - Lochbuehler,H, AU - Galli,C, AU - Reich,A, AU - Dietrich,G, AU - Hagemann,H, Y1 - 2008/03/13/ PY - 2008/3/15/pubmed PY - 2008/10/8/medline PY - 2008/3/15/entrez SP - 437 EP - 45 JF - European journal of anaesthesiology JO - Eur J Anaesthesiol VL - 25 IS - 6 N2 - BACKGROUND AND OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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. SN - 1365-2346 UR - https://www.unboundmedicine.com/medline/citation/18339212/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_ L2 - https://doi.org/10.1017/S0265021508003888 DB - PRIME DP - Unbound Medicine ER -