STUDIEREFERANSER Voluven - Fresenius Kabi
STUDIEREFERANSER Voluven - Fresenius Kabi
STUDIEREFERANSER Voluven - Fresenius Kabi
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Mai 2009<br />
<strong>STUDIEREFERANSER</strong><br />
<strong>Voluven</strong> ®<br />
MAI 2009
Reviews and Metaanalysis<br />
1. Baron J.F.<br />
A new hydroxyethyl starch: HES 130/0.4, <strong>Voluven</strong><br />
Transfusion alternatives in Transfusion medicine, Volume 1, No 2, April 2000<br />
2. Bork K.<br />
Pruritus precipitated by hydroxyethyl starch: a review<br />
Br J Dermatol. 2005 Jan; 152(1):3-12<br />
3. Cheng D, Bélisle S, Giffin M, Karkouti K, Martin J, James M,, Laliberte P, McCluskey S, muihead B, Pendergrast J,<br />
Sharpe M, Waters T<br />
Colloids for perioperative plasma volume expansion: systematic review with meta-analysis of controlled trials<br />
TATM 2007, 9 (Supp 1): S3<br />
4. Davidson IJ<br />
Renal Impact of fluid management with colloids: a compartive review<br />
European Journal of Anaesthesiology, 2006 Sept; 23 (9): 721-38<br />
5. Dieterich H.J.<br />
Recent developments in European colloid solutions<br />
The Journal of Trauma, May supplement 2003; 54, 26 –30<br />
6. James MF.<br />
The role of tetrastarches for volume replacement in the perioperative setting.<br />
Curr Opin Anaesthesiol. 2008 Oct;21(5):674-8. Review.<br />
7. Jungheinrich C<br />
The starch family: are they all equal? Pharmacokinetics and pharmacodynamics of hydroxyethyl starches<br />
TATM 2007, 9: 152-163<br />
8. Jungheinrich C, Neff TA.<br />
Pharmacokinetics of hydroxyethyl starch.<br />
Clin Pharmacokinet. 2005;44(7):681-99.<br />
9. Kozek-Langenecker SA, Jungheinrich C, Sauermann W, Van der Linden P.<br />
The effects of hydroxyethyl starch 130/0.4 (6%) on blood loss and use of blood products in major surgery: a pooled analysis of<br />
randomized clinical trials.<br />
Anesth Analg. 2008 Aug;107(2):382-90.<br />
10. Kozek-Langenecker SA.<br />
Effects of hydroxyethyl starch solutions on hemostasis.<br />
Anesthesiology. 2005 Sep;103(3):654-60.<br />
11. Perner A, Aneman A, Guttormsen AB, Kárason S, Tenhunen J.<br />
Preferences for colloid use in Scandinavian intensive care units. FLUIDS study investigators for the Scandinavian Critical<br />
Care Trials Group.<br />
Acta Anaesthesiol Scand. 2008 Jul;52(6):750-8.<br />
12. Sommermeyer K, Cech F & Schossow R<br />
Differences in chemical structures between waxy maize- and potato starch-based hydroxyethyl starch volume therapeutics<br />
Transfusion Alternatives in Transfusion Medicine 2007 9:127-133<br />
13. Van der Linden P, Ickx BE.<br />
The effects of colloid solutions on hemostasis.<br />
Can J Anaesth. 2006 Jun;53(6 Suppl):S30-9. Review.<br />
14. Wiedermann CJ.<br />
Hydroxyethyl starch--can the safety problems be ignored?<br />
Wien Klin Wochenschr. 2004 Sep 30;116(17-18):583-94. Review.<br />
15. Wiedermann CJ<br />
Systematic review of randomized clinical trials on the use of hydroxyethyl starch for fluid management in sepsis.<br />
BMC Emerg Med. 2008 Jan 24;8:1.<br />
Pre-Clinical and Animal Trials
16. Bepperling F., Opitz J., Leuschner J.<br />
HES 130/0.4, a new HES specification: Tissue storage after multiple infusions in rats.<br />
Critical Care (1999) Vol.3 Suppl.1 (abstract)<br />
17. Bepperling F., Opitz J., Leuschner J.<br />
Influence of HES 130/0.4 on survival rate in a lethal shock model in rats.<br />
British Journal of Anaesthesia (BJA) Vol. 82 Suppl.1 (1999) (abstract)<br />
18. Fries D, Haas T, Klingler A, Streif W, Klima G, Martini J, Wagner-Berger H, Innerhofer P<br />
Efficacy of fibrinogen and prothrombin complex concentrate used to reverse dilutional coagulopathy--a porcine model.<br />
Br J Anaesth. 2006 Oct;97(4):460-7. Epub 2006 Aug 1.<br />
19. Hoffmann J., Vollmar B., Laschke M., Inthorn D., Schildberg FW<br />
Hydroxyethylstarch (130 kD), but not crystalloid volume support, improves microcirculation during normotensive endotoxemia .<br />
Anaesthesiology 2002, 97:c460-70<br />
20. Johannes T, Egbert GM, Nohe B, Raat NJH, Unertl KE, Ince C.<br />
Influence of fliud resicitation on renal microvascular PO2 in a normotensive rat model of endotoxemia.<br />
Critcal care 2006, 10:R88<br />
21. Leuschner J., Opitz J. Winkler A., Scharpf R. and Bepperling F.<br />
Tissue Storage of 14C-Labelled Hydroxyethyl Starch (HES) 130/0.4 and HES 200/0.5 after Repeated Intravenous Administration<br />
to Rats.<br />
Drugs R&D 2003; 4 (6):331-338.<br />
22. Otsuki DA, Fantoni DT, Margarido CB, Marumo CK, Intelizano T, Pasqualacci CA, Costa Auler Jr JO<br />
Hydroxyethyl starch is superior to lactated Ringer as a replacement fluid in a pig model of acute normovolemic<br />
haemodilution.<br />
Br J Anaesth. 2007, 98(1):29-37<br />
23. Unger J, Haltern C, Kobela JB, Francis R, Rossaint R, Grosse-Siestrup C<br />
Hydroxyethyl starch 130 KD/0.4 and albumin improve CVVH biocompatibility whereas gelatin and hydroxyethyl starch<br />
200KD/0.5 lead to adverse side effects of CVVH in anesthetized pigs<br />
Shock, 2006; 25 (5): 533-545<br />
24. Yang Y<br />
Comparison of 6% hydroxyethyl starch with Ringer's solution on splanchic perfusion in canine with septic shock.<br />
Crit. Care 2006, 10 (Supp 1): P175<br />
Clinical studies with Volunteers<br />
25. Eckle K., Jungheinrich C.,Scharpf R., Wargenau M., Bepperling F.<br />
Pharmacokinetics and Tolerability of a New Hyrdoxyethylstarch Spesification 6% HES 130/0.4 (<strong>Voluven</strong>) after Single dose<br />
infusion in Subjects with renal impairment.<br />
Anesthesiol Intensiv Med. 200; 41:461 (abstract)<br />
26. Entholzner EK, Mielke LL, Calatzis AN, Feyh J, Hipp R, Hargasser<br />
Coagulation effects of a recently developed hydroxyethyl starch (HES 130/0.4) compared to hydroxyethyl starches with higher<br />
molecular weight.<br />
Acta Anaesthesiol Scand 2000 Oct;44(9):1116-21<br />
27. Fries D., Innerhofer P., Klinger A., Berresheim U., Calatzis A.<br />
The effect of combined administration of colloids and Ringer`s Lactate on the coagulation system – an in vitro study using TEG<br />
Critical Care, Vol. 5, Suppl 1, 2001 (abstract)<br />
28. James M.F.M., Latoo M.Y., Mythen M.G., Mutch M., Michaelis Ch., Roche A.M., Burdett E.<br />
Plasma volume changes associated with two hydroxyethyl starch colloids following acute hypovolaemia in volunteers.<br />
Anaesthesia, 59 (2004): 738-742<br />
29. Konrad, C. J., Markl T., Schuepfer G.<br />
In Vitro Effects of Different Medium Molecular Hydroxyethyl Starch Solutions and Lactated Ringer`s Solution on Coagulation<br />
Using Sonoclot.<br />
Anesth. Analg. 90 (2000) 274-9<br />
30. Schroeder, F., Standl, T., Nierhaus, A., Burmester, M.A., Schulte, J.<br />
Tissue oxygenation during acute normovolemic hemodilution with a newly designed hydroxyethyl starch solution in volunteers<br />
Journal of the American Society of Anesthesiologists, 93 (2000) (abstract)<br />
31. Standl, Burmeister, Schroeder, Currlin, Esch, Freitag, Schulte<br />
Hydroxyethyl Starch (HES) 130/0,4 Provides Larger and Faster Increases in Tissue Oxygen Tension in Comparison with<br />
Prehemodilution Values than HES 70/0,5 or HES 200/0,5 in Volunteers Undergoing Acute Normovolemic Hemodilution<br />
Anesth Analg 2003; 96: 963-43<br />
32. Waitzinger, J., Bepperling, F., Pabst, G., Opitz, J., Müller, M., Baron, JF.<br />
Pharmacokinetics and Tolerability of a New Hydroxyethylstarch (HES) Specification (HES 130/0.4) after Single Dose Infusion of<br />
6% or 10% Solution in Healthy Volunteers.<br />
Clin. Drug. Invest. 16 (1998) 151-160
33. Waitzinger, J., Bepperling, F., Pabst, G., Opitz, J., Fackelmayer, A., Boldt, J.<br />
Effect of a New Hydroxyethyl Starch (HES) Specification (6% HES 130/0.4) on Blood and Plasma Volumes after Bleeding in 12<br />
Healthy Male Volunteers.<br />
Clin. Drug. Invest. 17 (2) (1999) 119-125<br />
Cardiac and Aortic Surgery<br />
34. Boldt, J., Lehmann A., Römpert R., Haisch G., Isgro F.<br />
Volume therapy with a new hydroxyethyl starch solution in cardiac surgical patients before cardiopulmonary bypass.<br />
J Cardiothorac Vasc Anesth 14 (2000) 264-268<br />
35. Boks RH, Wijers MJ, Hofland J, Takkenberg JJ, Bogers AJ.<br />
Low molecular starch versus gelatin plasma expander during CPB: does it make a difference?<br />
Perfusion. 2007 Sep;22(5):333-7.<br />
36. Gallandat Huet RC, Siemons AW, Baus D, van Rooyen-Butijn WT, Haagenaars JA, van Oeveren W, Bepperling F.<br />
“A novel hydroxyethyl starch (<strong>Voluven</strong>) for effective perioperative plasma volume substitution in cardiac surgery.”<br />
Can J Anaesth 2000 Dec;47(12):1207-15<br />
37. Kasper SM, Meinert P, Kampe S., Görg C, Geisen C., Mehlhorn U., Diefenbach C.<br />
Large dose hydroxyethyl starch (HES) 130/0.4 does not increase Blood loss and transfusion reguirements in coronary artery<br />
bypass surgery compared with Hydroxyethylstarch 200/0.5 at recommended doses.<br />
Anasthesiology V99, No 2, Jul 2003.: 42-47.<br />
38. Morariu AM, Gu YJ, Huet RC, Siemons WA, Rakhorst G, Oeveren WV.<br />
Red blood cell aggregation during cardiopulmonary bypass: a pathogenic cofactor in endothelial cell activation?<br />
Eur J Cardiothorac Surg. 2004 Nov;26(5):939-46<br />
39. Riesmeier A, Schellhaass A, Boldt J, Suttner S.<br />
Crystalloid/colloid versus crystalloid intravascular volume administration before spinal anesthesia in elderly patients: the<br />
influence on cardiac output and stroke volume.<br />
Anesth Analg. 2009 Feb;108(2):650-4<br />
40. Rittoo D, Gosling P, Burnley S, Bonnici C, Millns P, Simms MH, Smith SR, Vohra RK<br />
Randomized study comparing the effects of hydroxyethyl starch solution with Gelofusine on pulmonary function in patients<br />
undergoing abdominal aortic aneurysm surgery.<br />
Br J Anaesth. 2004 Jan;92(1):61-6.<br />
41. Van der Linden PJ, De Hert SG, Deraedt D, Cromheecke S, De Decker K, Paep RD, Rodrigus I, Daper A, Trenchant A.<br />
Hydroxyethyl starch 130/0.4 versus modified fluid gelatin for volume expansion in cardiac surgery patients: the effects on<br />
perioperative bleeding and transfusion needs.<br />
Anesth Analg. 2005 Sep;101(3):629-34.<br />
42. Verheij J, van Lingen A, Raijmakers PG, Rijnsburger ER, Veerman DP, Wisselink W, Girbes AR, Groeneveld AB<br />
Effect of fluid loading with saline or colloids on pulmonary permeability, oedema and lung injury score after cardiac and major<br />
vascular surgery.<br />
Br J Anaesth. 2006 Jan;96(1):21-30. Epub 2005 Nov 25.<br />
43. Verheij J, van Lingen A, Beishuizen A, Christiaans H, de Jong J, Girbes A, Wisselink W, Rauwerda J, Huybregts M,<br />
Groeneveld J<br />
Cardiac response is greater for colloid than saline fluid loading after cardiac or vascular surgery<br />
Intensive Care Med, 2006 Jul; 32 (7): 1030-8<br />
44. Yap WW, Young D, Pathi V.<br />
Effects of gelatine and medium molecular weight starch as priming fluid in cardiopulmonary bypass--a randomised controlled<br />
trial.<br />
Perfusion. 2007 Jan;22(1):57-61.<br />
Major abdominal surgery<br />
45. Boldt J., Ducke M., Kumle B., Papsdorf M. And Zurmeyer E.L<br />
Influence of different volume replacement stratgies on inflammation and endothelial activation in the elderly undergoing major<br />
abdominal surgery.<br />
Intensive Care Med (2004) 30: 416-422.<br />
46. Boldt J, Schölhorn T, Mayer J, Piper S, Suttner S<br />
The value of an albumin based intravscular volume replacement strategy in elderly patients undergoing major abdominal<br />
surgery<br />
Anesth. Analg., 2006; 103: 191-9<br />
47. Haisch G., Boldt J., Krebs C., Kumle B., Suttner S., Schulz A.<br />
The influence of intravascular volume therapy with a new hydroxyethyl starch prepartion (6% HES 130/0.4) on coagulation in<br />
patients undergoing major abdominal surgery.<br />
Anesth Analg 2001; 92:565-71<br />
48. Harten J, Crozier JE, McCreath B, Hay A, McMillan DC, McArdle CS, Kinsella J.
Effect of intraoperative fluid optimisation on renal function in patients undergoing emergency abdominal surgery: a randomised<br />
controlled pilot study<br />
Int J Surg. 2008 Jun;6(3):197-204. Epub 2008 Mar 12.<br />
49. Ickx B.E., Bepperling F., Melot C., Schulman C., Van de Linden P.J.<br />
Plasma substitution effects of a new hydroxyethyl starch HES 130/0.4 compared with HES 200/0.5 during and after extended<br />
acute normovolemic haemodilution.<br />
British Journal of Anaesthesia 91 (2): 196-202 (2003)<br />
50. Lang K., Boldt J., Suttner S., Haisch G.<br />
Colloids vs. Crystalloids and tissue oxygen tension in patients undergoing major abdominal surgery<br />
Anesth Analg 2001; 93: 405-9<br />
51. Lang MD, Suttner MD, Boldt PhD<br />
Volume replacement with HES 130/0,4 may reduce the inflammatory response in patients undergoing major abdominal surgery<br />
Can J Anesth 2003 50:10 1009-1016<br />
52. Volta CA, Alvisi V, Campi M, Marangoni E, Alvisi R, Castellazzi M, Fainardi E, Manfrinato MC, Dallocchio F, Bellini T.<br />
Influence of different strategies of volume replacement on the activity of matrix metalloproteinases: an in vitro and in vivo study.<br />
Anesthesiology. 2007 Jan;106(1):85-91.<br />
Orthopedic surgery<br />
53. Gandhi S, Warltier D, Weiskopf R, Bepperling F, Baus D, Jungheirich C<br />
Volume substitution therapy during major orthopaedic surgery using <strong>Voluven</strong> (HES 130/0,4) or Hetastarch<br />
Anaesthesiology 2007; 106(6):1120-7<br />
54. Jungheinrich, C, Sauermann, W., Bepperling, F., Vogt, N.H.<br />
Volume efficacy and reduced influence on measures of coagulation using hydroxyethyl starch 130/0.4 (6%) with an optimized in<br />
vivo molecular weight in orthopedic surgery: a randomized, double-blind study.<br />
Drugs R & D 2004; 5, 1: 1-9<br />
55. Langeron O., Hbitz D., Faure E., Marty J. Coriat P.<br />
<strong>Voluven</strong>, a lower substituted novel hydroxyethyl starch (HES 130/0.4), causes fewer effects on coagulation in major orthopedic<br />
surgery than HES 200/0.5.<br />
Anesth Analg 2001;92:855-62<br />
56. Mittermayr M, Streif W, Haas T, Fries D, Velik-Salchner C, Klingler A, Oswald E, Bach C, Schnapka-Koepf M, Innerhofer<br />
P.<br />
Hemostatic changes after crystalloid or colloid fluid administration during major orthopedic surgery: the role of fibrinogen<br />
administration.<br />
Anesth Analg. 2007 Oct;105(4):905-17<br />
57. Walker R, McCarthy G<br />
Neutrophil elastase suppression by medium-molecular weight hydroxyethylstarch in orthopaedic surgery<br />
Crit. Care 2007, 11 (Supp 2): P407<br />
Urological Surgery<br />
58. Ellger B., Freyhoff J., Vogt M., Van Aken H.<br />
High dose volume replacement using HES 130/0.4 during major surgery does not alter coagulation<br />
European Journal of Anaesthesiology 2002, 10th ESA, Nice (abstract)<br />
Trauma patients<br />
59. Neff T., Jungheinrich C., Doelberg M., Sauerland A., Spahn D., Stocker R.<br />
Repetitive Infusion of the Novel Hydroxyethyl Starch 130/0,4 in Patients with severe Head Injury<br />
Anesth Analg 2003; 96: 1453-9<br />
Stroke patients<br />
60. Grauer MT., Baus D., Woessner R., Bepperling F., Kahles T., Georgi S.<br />
Effects on general safety and coagulation after long-term, high-dose volume therapy with 6% hydroxyethyl starch 130/0.4 in<br />
patients with acute ischemic stroke.<br />
Critical Care, Vol 5, Suppl 1, 2001-07-23 (abstract)<br />
61. Rudolf J.<br />
Hydroxyethyl starch for hypervolemic hemodilution in patients with acute ischemic stroke: a randomized, placebo-controlled<br />
phase II safety study.<br />
Cerebrovasc Dis 2002; 14:33-41<br />
62. Woessner R, Grauer MT, Dieterich HJ, Bepperling F, Baus D, Kahles T, Georgi S, Bianchi O, Morgenthaler M, Treib J.
Influence of a long-term, high-dose volume therapy with 6% hydroxyethyl starch 130/0.4 or crystalloid solution on<br />
hemodynamics, rheology and hemostasis in patients with acute ischemic stroke. Results of a randomized, placebo-controlled,<br />
double-blind study.<br />
Pathophysiol Haemost Thromb. 2003 May-Jun;33(3):121-6.<br />
Renal function<br />
63. Blasco V, Leone M, Antonini F, Geissler A, Albanèse J, Martin C<br />
Comparison of the novel hydroxyethylstarch 130/0.4 and hydroxyethylstarch 200/0.6 in brain-dead donor resuscitation on renal<br />
function after transplantation.<br />
British Journal of Anaesthesia feb 2008 100(4):504-508; doi:10.1093/bja/aen001<br />
64. Boldt J, Brosch C, Ducke M, Papsdorf, Lemann A<br />
Influence of volume therapy with a modern hydroxyethylstarch praparation on kidney function in cardiac surgery patients with<br />
compromised renal function: A comparason with human albumin.<br />
Crit Care Med 2007 Vol 35, No.11<br />
65. Boldt, Brenner, Lehmann, Lang, Kumle, Werling<br />
Influence of two different volume replacement regimens on renal function in eldery patients undergoing cardiac surgery:<br />
Comparison of a new starch preparation with gelatin<br />
Intensive care Med 2003, 29: 763-769.<br />
66. Boldt J, Bosch K, Röhm K, Papsdorf M, Mengistu A<br />
Comparison of the effects of gelatin and a modern hydroxyethyl starch solution on renal function and inflammatory response in<br />
elderly cardiac surgery patients<br />
Br J Anaesth feb 2008, 100(4):457-64<br />
67. Boldt J, Brosch Ch, Röhm K, Lehmann A, Mengistu A, Suttner S.<br />
Is albumin administration in hypoalbuminemic elderly cardiac surgery patients of benefit with regard to inflammation,<br />
endothelial activation, and long-term kidney function?<br />
Anesth Analg. 2008 Nov;107(5):1496-503.<br />
68. Fenger-Eriksen C, Hartig Rasmussen C, Kappel Jensen T, Anker-Moller E, Heslop J, Frokaer J, Tonnesen E.<br />
Renal effects of hypotensive anaesthesia in combination with acute normovolaemic haemodilution with hydroxyethyl starch<br />
130/0.4 or isotonic saline.<br />
Acta Anaesthesiol Scand. 2005 Aug;49(7):969-74.<br />
69. Godet G, Lehot J,Janvier G, Steib A, De Casto V and Coriat P.<br />
Safety of HES 130/0.4 (<strong>Voluven</strong>) in patients with preoperative renal dysfunction undergoing abdominal aortic surgery: a<br />
prospective, randomized, controlled, parallel-group multicentre trial.<br />
Eur J Anaesthesiol. 2008 Dec;25(12):986-94. Epub 2008 May 20. Erratum in: Eur J Anaesthesiol. 2008 Dec;25(12):1042.<br />
70. Jakob SM.<br />
Prevention of acute renal failure--fluid repletion and colloids.<br />
Int J Artif Organs. 2004 Dec;27(12):1043-8.<br />
71. Jungheinrich, Scarph, Wargenau, Bepplinger, Baron<br />
The Pharrmacokintics and Tolerability of an Intravenous Infusuon of the New Hydroxyethyl Starch 130/0,4 in Mild-to-Severe<br />
Renal Impairment<br />
Anesth Analg 2002; 95:544-51<br />
72. Mahmood A, Gosling P, Vohra RK.<br />
Randomized clinical trial comparing the effects on renal function of hydroxyethyl starch or gelatine during aortic aneurysm<br />
surgery.<br />
Br J Surg. 2007 Apr;94(4):427-33<br />
73. Sakr Y, D.Payen, K.Reinhart, Sipmann FS, Zavala E, Bewlwy J, Marx G, Vincent JL<br />
Effects of hydroxyehtylstarch on renal function in criticall ill patients.<br />
British Journal of Anaesthesia 98(2):216-24 (2007).<br />
74. Schortgen F, Girou E, Deye N, Brochard L; CRYCO Study Group<br />
The risk associated with hyperoncotic colloids in patients with shock.<br />
Intensive Care Med. 2008 Dec;34(12):2157-68. Epub 2008 Aug 7.<br />
75. Unger JK, Haltern C, Dohmen B, Gressner A, Grosse-Siestrup C, Groneberg DA, Rossaint R.<br />
Albumin and hydroxyethyl starch 130 kDa/0.4 improve filter clearance and haemocompatibility in haemo- and plasmafiltrationan<br />
in vitro study.<br />
Nephrol Dial Transplant. 2005 Sep;20(9):1922-31. Epub 2005 May 31.<br />
Paediatric patients<br />
76. Gapay A, Siao S, Merin F, Merin A, Diaz M, Tizon S, Baquilod S, Garra N, Kulkarni H.<br />
HES 130/0,4 in children with severe sepsis: an observational case series.<br />
Trans Alt in Trans Med 2007, 9 (suppl 1), 31-59.<br />
77. Haas T, Preinreich A, Oswald E, Pajk W, Berger J, Kuehbacher G, Innerhofer P.
Effects of albumin 5% and artificial colloids on clot formation in small infants.<br />
Anaesthesia. 2007 Oct;62(10):1000-7.<br />
78. Hanart C, Khalife M, De Villé A, Otte F, De Hert S, Van der Linden P<br />
Perioperative volume replacement in children undergoing cardiac surgery: Albumin versus hydroxyethyl starch<br />
130/0.4.<br />
Crit Care Med. 2009 Dec 26. [Epub ahead of print]<br />
79. Khalife M, Hanart C, De Ville A, De Hert S, Van der Linden P<br />
6% HES 130/0.4 versus 4% albumin for volume replacement in paediatric cardiac surgery: cyanotic congenital disease<br />
European Journal of Anaesthesia 2006, Vol 23 (37): A-300 (abstract)<br />
80. Savvina IA.<br />
Intraoperative <strong>Voluven</strong> use in paediatric Neurosurgical patients<br />
Poster / oral presentation ESICM 16 th Annual congress Amsterdam, 2003<br />
81. Saudan S, M. Pellegrini, D. Ceroni, A. Kaelin, W. Habre<br />
Hydroxyethyl starch 130/0.4 versus 5% human albumin in children undergoing spinal fusion: safety and efficiency<br />
European Journal of Anaesthesia 2006, Vol 23 (37): A-662 (abstract)<br />
82. Standl T, Lochbuehler H, Galli C, Reich A, Dietrich G, Hagemann H.<br />
HES 130/0.4 (<strong>Voluven</strong>) or human albumin in children younger than 2 yr undergoing non-cardiac surgery. A prospective,<br />
randomized, open label, multicentre trial.<br />
Eur J Anaesthesiol. 2008 Jun;25(6):437-45. Epub 2008 Mar 13.<br />
83. Sung KC, Kum Suk P, Mi Ja Y and Kyoung Ok K.<br />
Effects of intravascular volume therapy using hydroxyethyl starch (130/0.4) on post-operative bleeding and transfusion<br />
requirements in children undergoing cardiac surgery: a randomized clinical trial.<br />
Acta Anaesthesiol Scand, 40:108-111, 2006<br />
84. Van der Linden P, Khalife C, Hanart C, De Groote F, De Ville A<br />
Fluid management in children undergoing surgery with cardiopulmonary bypass for congenital heart disease: Is albumin still the<br />
best choice?<br />
Transf Alt in Tranf Med 2006, Vol 8 nunb 1: 22-24<br />
Cesarean Section<br />
85. Economou S, Iatreli I, Saridou M, Roubos P, Kadilieraki N, Georgakis T, Chatzikonstandi C, Rali S, Pavlopoulos F<br />
Hemodynamic stability of patients under spinal anesthesia. Comparison of two methods of volume preloading<br />
European Journal of Anaesthesia 2006, Vol 23 (37): A-411 (abstract)<br />
86. Ko JS, Kim CS, Cho HS, Choi DH<br />
A randomized trial of crystalloid versus colloid solution for prevention of hypotension during spinal or low-dose combined<br />
spinal-epidural anesthesia for elective caesarean delivery.<br />
International Journal of obstetric Anesthesia. (2007) 16,8-12 (abstract)<br />
87. Madi-Jebara SN, Ghosn A, Cherfane A, Antakly MC and Yazigi A.<br />
Prevention of hypotension after spinal anesthesia for cesarean section: <strong>Voluven</strong> (6 % hydroxyethyl starch 130/0.4) versus<br />
lactated ringers solution.<br />
Lebanese Med J 2008; 56(4):203-6<br />
88. Secure MJ, Camino G, Piccolo M and De Nicola A.<br />
Effectiveness of volume preload before spinal anaesthesia for caesarean section: 6% hydroxyethyl starch 130/0.4 vs lactated<br />
ringers solution.<br />
San Leonardo Hospital, Dept. of Anaestesiology, Pompei Italy (abstract)<br />
Septic patients<br />
89. Dieterich HJ<br />
Hydroxyethyl starch and inflammation.<br />
Transf Alt in Tranf Med 2007, 9 (Suppl 1), 1-30.<br />
90. Dieterich HJ, Weissmüller T, Rosenberg P, Eltzschig H<br />
Effect of hydroxyethyl starch on vascular leak syndrome and neutrophil accumulation during hypoxia<br />
Crit Care Med, 2006; 34 (6): 1775-82<br />
91. Ertmer C, Rehberg S, Lange M, Bröking K, Morelli A, Van Aken H, Rübig E, vom Roth F, Westpahl M.<br />
Hemodynamic and renal effects of different starch solutions in ovine endotoxemia<br />
Poster / oral presentation ESICM 20 th Annual congress Berlin, 2007<br />
92. Galstyan GM, Serebriysky II, Berkovsky AL, Vasiliew SA, Rudakova VE, Sergeeva EV, Gorodetsky VM<br />
Influence of hydroxyethyl starch (HES) on Hemostasis in patients (PTS) with sepsis<br />
Intensive Care Medicine, 2006: 32 (Suppl 1): S0692<br />
93. Marx G, Pedder S, Smith L, Swaraj S, Grime S, Stockdale H, Leuwer M<br />
Resuscitation from septic shock with capillary leakage: hydroxyethyl starch (130 kd), but not Ringer's solution maintains plasma<br />
volume and systemic oxygenation.<br />
Shock. 2004 Apr;21(4):336-41.
94. Meyer P, Permet I, Hejblum G, Baudel J, Maury E, Offenstadt G, Guidet B<br />
Haemodilution induced by hydroxyethyl starches 130/0.4 is similar in septic and non-septic patients.<br />
Acta Anaesthesiol Scand. 2008 Feb;52(2):229-35. Epub 2007 Nov 22.<br />
95. Palumbo D, Servillo G, D'Amato L, Volpe ML, Capogrosso G, De Robertis E, Piazza O, Tufano R<br />
The effects of hydroxyethyl starch solution in critically ill patients<br />
Minerva Anestesiol, 2006; 72: 655-64<br />
96. Turani, Rosati, Redi, Leonardis, Celeste, Colella, Curatola<br />
Cardiac and volumetric response to two different colloids in septic patients<br />
Poster / oral presentation ESICM 16 th Annual congress Amsterdam, 2003<br />
Coagulation<br />
97. Ahn HJ, Yang M, Gwak MS, Koo MS, Bang SR, Kim GS, Lee SK.<br />
Coagulation and biochemical effects of balanced salt-based high molecular weight vs saline-based low molecular weight<br />
hydroxyethyl starch solutions during the anhepatic period of liver transplantation.<br />
Anaesthesia. 2008 Mar;63(3):235-42.<br />
98. Boldt J, Suttner S, Brosch C, Lehmann A, Mengistu A.<br />
Influence on coagulation of a potato-derived hydroxethylstarch (HES 130/0.42) and a maize-derived hydroxethylstarch (HES<br />
130/0.4) in patients undergoing cardiac surgery.<br />
Br J Anaesth. 2009 Feb;102(2):191-7. Epub 2008 Dec 10.<br />
99. Boldt J, Mengistu A, Seyfert UT, Hellstern P.<br />
The impact of a medium molecular weight, low molar substiution hydroxyethyl starch dissolved in a physiologically balanced<br />
electrolyte solution on blood coagulation and platlet function in vitro.<br />
Vox Sanguinis (2007) 93, 139-144<br />
100. Boldt J, Wolf M, Mengistu A<br />
A new plasma-adapted Hydroxyethylstarch praparation: In vitro coagulation studies using thrombelastography and whole blood<br />
aggregometry<br />
Anesthesia Ann. Vol 104, No2, feb, 2007: 425-430<br />
101. Boldt J, Haisch G, Sutter S, Kumle B, Scellhaass A<br />
Effects of a new modified, balanced hydroxyethyl starch preparation (Hextend) on measures of coagulation<br />
Brit Jour of Anaesth 2002, 89 (5): 722-8<br />
102. Bulanov A, Sulutko E, Scherbakova O, Lubimova L, Gelnova E, Sudeikina N.<br />
Effects of different colloid solutions on clot formation in healty donors.<br />
Trans Alt in Trans Med 2007, 9 (suppl 1), 31-59.<br />
103. Chen G, Yan M, Lu Q, Gong M<br />
Effects of two different hydroxyethyl starch solutions (HES 200/0,5 vs. HES 130/0,4) on the expression of platelet<br />
membrane glycoprotein.<br />
Acta Anaesthesiol Scand. 2006, 50: 1089-1094<br />
104. Ellger, Freyholdt, Vogt, Aken, Marcus, Booke<br />
High-dose volume replacement using HES 130/0,4 during major surgery. Impact on coagulation and incidence of postoperative<br />
iching.<br />
Ned Tids voor Anesth, 2006 vol 19: 63-68<br />
105. Felfernig, Franz, Braunlich, Fohringer, Kozek-Langenecker<br />
The effects of hydroxyethyl starch solutions on thromboelastography in preoperative male patients<br />
Acta Anaesthesiologica Scandinavia 2003: 47: 70-73<br />
106. Fenger-Eriksen C, Anker-Moller E, Heslop J, Ingerslev J, Sorensen B<br />
Thrombelastographic whole blood clot formation after ex vivo addition of plasma substitutes: improvements of the induced<br />
coagulopathy with fibrinogen concentrate.<br />
Br J Anaesth. 2005 Mar;94(3):324-9. Epub 2004 Dec 17.<br />
107. Franz, A., Braeunlich, P., Foringer C., Kozek A.<br />
The effects of hydroxyethyl starches of varying molecular weights on platelet function.<br />
Anesth Analg 2001, 92:1402-7<br />
108. Gandhe U, Shetty V, Pande K, Kulkarni S, Kulkarni H<br />
Volume requirement, coagulation profile and outcome parameter comparison of gelatin versus hydroxyethyl starch in coronary<br />
artery bypass graft<br />
Transfusion Alternatives in Transfusion Medicine 2006, 8 (Supp 1): P63 (abstract)<br />
109. Kang JG, Ahn HJ, Kim GS, Hahm TS, Lee JJ, Gwak MS, Choi SJ.<br />
The hemostatic profiles of patients with Type O and non-O blood after acute normovolemic hemodilution with 6% hydroxyethyl<br />
starch (130/0.4).<br />
Anesth Analg. 2006 Dec;103(6):1543-8.
110. Niemi TT, Kuitunen AH.<br />
Artificial colloids impair haemostasis. An in vitro study using thromboelastometry coagulation analysis.<br />
Acta Anaesthesiol Scand. 2005 Mar;49(3):373-8.<br />
111. Scharbert G., Deusch E., Kress H.G., Greher M., Gustorff B., Kozek-Langenecker S.A.<br />
Inhibation of platelet function by hydroxyethyl starch solutions in cronic pain patients undergoing peridural anesthesia..<br />
Anesth Analg 2004; 99: 823-7<br />
112. Schramko AA, Suojaranta-Ylinen RT, Kuitunen AH, Kukkonen SI, Niemi TT.<br />
Rapidly degradable hydroxyethyl starch solutions impair blood coagulation after cardiac surgery: a prospective randomized trial.<br />
Anesth Analg. 2009 Jan;108(1):30-6.<br />
113. von Roten I, Madjdpour C, Frascarolo P, Burmeister MA, Fisch A, Schramm S, Bombeli T, Spahn DR.<br />
Molar substitution and C2/C6 ratio of hydroxyethyl starch: influence on blood coagulation.<br />
Br J Anaesth. 2006 Apr;96(4):455-63. Epub 2006 Feb 7.<br />
Liver transplantation<br />
114. Costa M., Ponpei L., Della Rocca G.<br />
Blood substitution consumption and coagulation changes: 200/0.5 vs. HES 130/0.4 hydroxyethyl starch administration<br />
Critical Care, Vol. 7, suppl. 2, March 2003, (abstract)<br />
115. Pereira L, Oliveira D, Cipriano MA, Neves S, Viana JS<br />
Hydroxyethylstarch 130/0.4 in liver transplantation - evaluation of the effects on graft function and post-operative course<br />
European Journal of Anaesthesia 2006, Vol 23 (37): A-299 (abstract)<br />
Other studies of interest<br />
116. Base E, Standl T, Mahl C, Jungheinrich C.<br />
Comparison of 6% HES 130/0.4 in a balanced electrolyte solution versus 6% HES 130/0.4 in normal saline solution in<br />
cardiac surgery.<br />
Crit. Care 2006, 10 (Supp 1): P176<br />
117. Boldt J., Suttner S., Hüttner I., Kumle B., Piper S., Krumholz W.<br />
Are cost of a crystalloid-based volume replacement regimen lower than of a colloid-based volume replacement<br />
strategy?<br />
Infus Ther Transfus Med 2001;28:144-149<br />
118. Brandstrup B,Tonnesen H, Beier-Holgersen R, Hjortso E, Ording H, Lindorff-Larsen K, Rasmussen MS, Lanng C, Wallin<br />
L, Iversen LH, Gramkow CS, Okholm M, Blemmer T, Svendsen PE, Rottensten HH, Thage B, Riis J, Jeppesen IS, Teilum<br />
D, Christensen AM, Graungaard B, Pott F.<br />
Effects of intravenous fluid restriction on postoperative complications: comparison of<br />
two perioperative fluid regimens: a randomized assessor-blinded multicenter trial.<br />
Ann Surg 2003; 238: 641-648<br />
119. Habler O, Schwenzer K, Zimmer K, Prager M, Konig U, Oppenrieder K, Pape A, Steinkraus E, Reither A, Buchrot A,<br />
Zwissler B.<br />
Effects of standardized acute normovolemic hemodilution on intraoperative allogeneic blood transfusion in patients undergoing<br />
major maxillofacial surgery.<br />
Int J Oral Maxillofac Surg. 2004 Jul;33(5):467-75.<br />
120. Kasper, SM., Strömich, A., Kampe S, Radbruch L.<br />
Evaluation of a new hydroxyethyl starch solution (HES 130/0.4) in patients<br />
undergoing preoperative autologous blood donation<br />
J Clin Anesth 2001 Nov;13(7):486-90<br />
121. Kim DH, Beez M, Kulkarni H.<br />
Comparative Hemodynamic Evaluation on Hydroxyethylstarch (HES 130/0,4) and Albumin in High Risk Surgical Patients<br />
Transfusion Alternatives in Transfusion Medicine 2005; 7 (1): 79. Poster presented at NATA 2005<br />
122. Klemm E, Bepperling F, Burschka MA, Mösges R; Study Group.<br />
Hemodilution therapy with hydroxyethyl starch solution (130/0.4) in unilateral idiopathic sudden sensorineural hearing loss: a<br />
dose-finding, double-blind, placebo-controlled, international multicenter trial with 210 patients.<br />
Otol Neurotol. 2007 Feb;28(2):157-70.<br />
123. Neff TA, Fischler L, Mark M, Stocker R, Reinhart WH.<br />
The influence of two different hydroxyethyl starch solutions (6% HES 130/0.4 and 200/0.5) on blood viscosity.<br />
Anesth Analg. 2005 Jun;100(6):1773-80.<br />
124. Schnuelle P, Johannes van der Woude F.<br />
Perioperative fluid management in renal transplantation: a narrative review of the literature.<br />
Transpl Int. 2006 Dec;19(12):947-59
<strong>Voluven</strong> “<strong>Fresenius</strong> <strong>Kabi</strong>”<br />
Kolloidosmotisk oppløsning ATC-nr.:B05A A07<br />
INFUSJONSVÆSKE, oppløsning 60 mg/ml: 1000 ml inneh.: Poly(O-2-hydroksyetyl)stivelse (HES 130/0,4) 60<br />
g, natriumklorid 9 g, saltsyre, natriumhydroksid, vann til injeksjon til 1000 ml. Elektrolyttinnh.: Na+ 154 mmol,<br />
Cl- 154 mmol. pH 4-5,5. Osmolaritet: 308 mosmol/liter. Titrerbar aciditet:
Dosering: Til kontinuerlig i.v. infusjon. De første 10-20 ml infunderes langsomt. I denne perioden må<br />
pasienten observeres nøye pga. faren for anafylaktoide reaksjoner. Dagsdose og infusjonshastighet<br />
bestemmes av pasientens blodtap, den hemodynamiske status og hemodilusjonseffekten. Maks. daglig dose<br />
er 50 ml/kg kroppsvekt/døgn. <strong>Voluven</strong> kan administreres gjentatte ganger over flere dager i henhold til<br />
pasientens behov. Behandlingens varighet avhenger av hypovolemiens grad og varighet, den<br />
hemodynamiske status og hemodilusjonen. Erfaring med bruk av maks. daglig dose gitt over lengre perioder<br />
er begrenset. Barn: Begrensede kliniske data er tilgjengelig. En gjennomsnittsdose tilsvarende 16 ± 9 ml/kg<br />
kroppsvekt er trygt og vel tolerert av 41 barn, inkl. nyfødte og spedbarn (
For mer informasjon<br />
Kontakt Produktsjef<br />
Jørgen Sørensen på<br />
22 58 80 00 el. 917 61 912<br />
jorgen.sorensen@fresenius-kabi.com