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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

Published online by Cambridge University Press:  01 June 2008

T. Standl*
Affiliation:
Academic Hospital Solingen, Department of Anesthesia and Critical Care Medicine, Solingen, Hannover, Germany
H. Lochbuehler
Affiliation:
Childrens’ Hospital Dr. von Haunersches Kinderspital, Munich, Hannover, Germany
C. Galli
Affiliation:
University Clinics, Department of Anesthesiology, Freiburg, Hannover, Germany
A. Reich
Affiliation:
University Clinics, Department of Anesthesiology and Operative Intensive Medicine, Münster, Hannover, Germany
G. Dietrich
Affiliation:
University of Giessen, Department of Anesthesiology and Operative Intensive Medicine, Giessen, Hannover, Germany
H. Hagemann
Affiliation:
University Clinics, Department of Anesthesiology, Hannover, Germany
*
Department of Anesthesia and Critical Care Medicine, Academic Hospital Solingen, Gotenstrasse 1, 42653 Solingen, Germany. E-mail: standl@klinikumsolingen.de; Tel: +49 212 547 2600; Fax: +49 212 547 2234
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Summary

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.

Type
Original Article
Copyright
Copyright © European Society of Anaesthesiology 2008

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References

1.Schwarz, U. Intraoperative fluid therapy in infants and young children. Anaesthesist 1999; 48: 4150.CrossRefGoogle ScholarPubMed
2.Nadel, S, De Munter, C, Britto, J, Levin, M, Habib, P. Albumin: saint or sinner. Arch Dis Child 1998; 79: 384385.CrossRefGoogle ScholarPubMed
3.Boldt, J, Knothe, C, Schindler, H, Hammermann, H, Dapper, F, Hempelmann, G. Volume replacement with hydroxyethyl starch solution in children. Br J Anaesth 1993; 70: 661665.CrossRefGoogle ScholarPubMed
4.Gregori, L, Maring, JA, MacAuley, C et al. Partitioning of TSE infectivity during ethanol fractionation of human plasma. Biologicals 2004; 32: 110.CrossRefGoogle ScholarPubMed
5.Hausdoerfer, J, Hagemann, H, Heine, J. Comparison of volume substitutes 5 percent human albumin and 6 percent hydroxyethyl starch (40,000/0.5) in pediatric anesthesia. Anaesth Intensivther Notfallmed 1986; 21: 137142.Google Scholar
6.Aly Hassan, A, Lochbuehler, H, Frey, L, Messmer, K. Global tissue oxygenation during normovolaemic haemodilution in young children. Paediatr Anaesth 1997; 7: 197204.CrossRefGoogle ScholarPubMed
7.So, KW, Fok, TF, Ng, PC, Wong, WW, Cheung, KL. Randomized controlled trial of colloid or crystalloid in hypotensive preterm children. Arch Dis Child 1997; 76: F43F46.CrossRefGoogle ScholarPubMed
8.Stoddart, PA, Rich, P, Sury, MR. A comparison of 4.5% humans albumin solution and Haemaccel in neonates undergoing major surgery. Paediatr Anaesth 1996; 6: 103106.CrossRefGoogle ScholarPubMed
9.Vogt, NH, Bothner, U, Lerch, G, Lindner, KH, Georgieff, M. Large-dose administration of 6% hydroxyethyl starch 200/0.5 in total hip arthroplasty: plasma homeostasis, hemostasis, and renal function compared to use of 5% human albumin. Anesth Analg 1996; 83: 262268.CrossRefGoogle Scholar
10.Laxenaire, MC, Charpentier, C, Feldman, L. Anaphylactoid reactions to colloid plasma substitutes: frequency, risk factors, mechanisms. Ann Fr Anesth Reanim 1994; 13: 301310.CrossRefGoogle ScholarPubMed
11.Leuschner, J, Opitz, J, Winkler, A, Scharpf, R, Bepperling, F. Tissue storage of 14C-labeled hydroxyethyl starch (HES) 130/0.4 and HES 200/0.5 after repeated intravenous administration to rats. Drugs R D 2003; 4: 331338.CrossRefGoogle Scholar
12.Jungheinrich, C, Neff, TA. Pharmacokinetics of hydroxyethyl starch. Clin Pharmacokinet 2005; 44: 681699.CrossRefGoogle ScholarPubMed
13.Strauss, RG, Stansfield, C, Henriksen, RA, Villhauer, PJ. Pentastarch may cause fewer effects on coagulation than hetastarch. Transfusion 1988; 28: 257260.CrossRefGoogle ScholarPubMed
14.Treib, J, Haass, A, Pindur, G et al. Increased hemorrhagic risk after repeated infusion of highly substituted medium molecular weight hydroxyethyl starch. Arzneim Forsch Drug Res 1997; 47: 1822.Google ScholarPubMed
15.Haisch, G, Boldt, J, Krebs, C, Kumle, B. The influence of intravascular volume therapy with a new hydroxyethyl starch preparation (6% HES 130/0.4) on coagulation in patients undergoing major abdominal surgery. Anesth Analg 2001; 92: 565571.CrossRefGoogle ScholarPubMed
16.Jungheinrich, C, Sauermann, W, Bepperling, F, Vogt, NH. Volume efficacy and reduced influence on measures of coagulation using hydroxyethyl starch 130/0.4 (6%) with an optimised in vivo molecular weight in orthopaedic surgery – a randomised, double-blind study. Drugs R D 2004; 5: 19.CrossRefGoogle ScholarPubMed
17.Lang, K, Boldt, J, Suttner, S, Haisch, G. Colloids versus crystalloids and tissue oxygen tension in patients undergoing major abdominal surgery. Anesth Analg 2001; 93: 405409.Google ScholarPubMed
18.Standl, T, Burmeister, MA, Schroeder, F et al. Hydroxyethyl starch (HES) 130/0.4 provides larger and faster increases in tissue oxygen tension in comparison with prehemodilution values than HES 70/0.5 or HES 200/0.5 in volunteers undergoing acute normovolemic hemodilution. Anesth Analg 2003; 96: 936943.CrossRefGoogle Scholar
19.Neff, TA, Fischler, L, Mark, M, Stocker, R, Reinhart, WH. The influence of two different hydroxyethyl starch solutions (6% HES 130/0.4 and 200/0.5) on blood viscosity. Anesth Analg 2005; 100: 17731780.CrossRefGoogle Scholar
20.Blumer, JL. Off-label use of drugs in children. Pediatrics 1999; 104: 598602.CrossRefGoogle ScholarPubMed
21.Waitzinger, J, Bepperling, F, Pabst, G, Opitz, J, Müller, M, Baron, JF. Pharmacokinetics and tolerability of a new hydroxyethyl starch (HES) specification [HES (130/0.4)] after single-dose infusion of 6% and 10% solutions in healthy volunteers. Clin Drug Invest 1998; 16: 151160.CrossRefGoogle Scholar
22.Waitzinger, J, Bepperling, F, Pabst, G et al. Hydroxyethyl starch (HES) [130/0.4], a new HES specification. Pharmacokinetics and safety after multiple infusions of 10% solution in healthy Volunteers. Drugs R D 2003; 4: 149157.Google Scholar
23.Jungheinrich, C, Scharpf, R, Wargenau, M, Bepperling, F, Baron, JF. The pharmacokinetics and tolerability of an intravenous infusion of the new hydroxyethyl starch 130/0.4 (6%, 500 mL) in mild-to-severe renal impairment. Anesth Analg 2002; 95: 544551.CrossRefGoogle ScholarPubMed
24.Gallandat Huet, RCG, Siemons, AW, Baus, D et al. A novel hydroxyethyl starch (Voluven®) for effective perioperative plasma volume substitution in cardiac surgery. Can J Anesth 2000; 47: 12071215.CrossRefGoogle ScholarPubMed
25.Langeron, O, Doelberg, M, Ang, ET, Bonnet, F, Capdevila, X, Coriat, P. Voluven®, a lower substituted novel hydroxyethyl starch (HES 130/00.4), causes fewer effects on coagulation in major orthopedic surgery than HES 200/0.5. Anesth Analg 2001; 92: 855862.CrossRefGoogle Scholar
26.James, MF, Latoo, MY, Mythen, MG et al. Plasma volume changes associated with two hydroxyethyl starch colloids following acute hypovolaemia in volunteers. Anaesthesia 2004; 59: 738742.CrossRefGoogle ScholarPubMed
27.Gandhi, S, Warltier, D, Weiskopf, R, Bepperling, F, Baus, D, Jungheinrich, C. Volume substitution therapy with HES 130/0.4 (Voluven) versus HES 450/0.7 (hetastarch) during major orthopedic surgery. Crit Care 2005; 9 (Suppl. 1): 206.CrossRefGoogle Scholar
28.Duke, T, Molyneux, EM. Intravenous fluids for seriously ill children: time to reconsider. Lancet 2003; 362: 13201323.CrossRefGoogle ScholarPubMed
29.Shafiee, MAS, Bohn, D, Hoorn, EJ, Halperin, ML. How to select optimal maintenance intravenous fluid therapy. Q J Med 2003; 96: 601610.CrossRefGoogle ScholarPubMed
30.Liet, JM, Bellouin, AS, Boscher, C, Lejus, C, Rozé, JC. Plasma volume expansion by medium molecular weight hydroxyethyl starch in neonates: a pilot study. Pediatr Crit Care Med 2003; 4: 305307.CrossRefGoogle ScholarPubMed
31.Paul, M, Dueck, M, Herrmann, J, Holzki, J. A randomized, controlled study of fluid management in infants and toddlers during surgery: hydroxyethyl starch 6% (HES 70/0.5) vs. lactated Ringer’s solution. Pediatric Anesth 2003; 13: 603608.CrossRefGoogle ScholarPubMed
32.Chong Sung, K, Kum Suk, P, Mi Ja, Y, Kyoung Ok, K. Effects of intravascular volume therapy using hydroxyethyl starch (130/0.4) on post-operative bleeding and transfusion requirements in children undergoing cardiac surgery: a randomized clinical trial. Acta Anaesthesiol Scand 2006; 50: 108111.CrossRefGoogle ScholarPubMed
33.Wills, BA, Nguyen, MD, Ha, TL et al. Comparison of three fluid solutions for resuscitation in dengue shock syndrome. N Engl J Med 2005; 353: 877889.CrossRefGoogle ScholarPubMed
34.Bjorksten, B, Hattevig, G, Kjellman, B, Ahlstedt, S, Richter, W. Dextran-reactive antibodies in healthy infants and toddlers – relation to type of feeding. Int Arch Allergy Appl Immunol 1982; 69: 174178.CrossRefGoogle ScholarPubMed