CONTRA: Hydroxyethyl starch solutions are unsafe in critically ill patients

Intensive Care Medicine

Volumn 35, Issue 8, 2009, Pages 1337-1342

  Hartog, Christiane ^a   Reinhart, Konrad ^a  

^a FRIEDRICH SCHILLER UNIVERSITY JENA   (Germany)

Author keywords

Colloids; Critically ill; Crystalloids; Efficacy; Hydroxyethyl starch; Safety

Indexed keywords

HETASTARCH;

ARTICLE; BLOOD CLOTTING; BLOOD CLOTTING DISORDER; BLOOD TRANSFUSION; CLINICAL TRIAL; CONTROLLED STUDY; CRYSTALLOID; DENGUE; DRUG EFFICACY; DRUG SAFETY; HUMAN; KIDNEY FUNCTION; MORTALITY; NEPHROTOXICITY; OUTCOME ASSESSMENT; PRURITUS; RESUSCITATION; RISK FACTOR; TISSUE PRESERVATION;

COLLOIDS; CRITICAL ILLNESS; HETASTARCH; HUMANS; ISOTONIC SOLUTIONS; PLASMA SUBSTITUTES;

EID: 67650998510     PISSN: 03424642     EISSN: 14321238     Source Type: Journal    
DOI: 10.1007/s00134-009-1521-5     Document Type: Article

References (48)

1. Perel P, Roberts I (2007) Colloids versus crystalloids for fluid resuscitation in critically ill patients. Cochrane Database Syst Rev (Online):CD000567
2. BA Wills MD Nguyen TL Ha TH Dong TN Tran TT Le VD Tran TH Nguyen VC Nguyen K Stepniewska NJ White JJ Farrar 2005 Comparison of three fluid solutions for resuscitation in dengue shock syndrome N Engl J Med 353 877 889
3. S Finfer R Bellomo N Boyce J French J Myburgh R Norton 2004 A comparison of albumin and saline for fluid resuscitation in the intensive care unit N Engl J Med 350 2247 2256
4. FM Brunkhorst C Engel F Bloos A Meier-Hellmann M Ragaller N Weiler O Moerer M Gruendling M Oppert S Grond D Olthoff U Jaschinski S John R Rossaint T Welte M Schaefer P Kern E Kuhnt M Kiehntopf C Hartog C Natanson M Loeffler K Reinhart 2008 Intensive insulin therapy and pentastarch resuscitation in severe sepsis N Engl J Med 358 125 139
5. MM Wilkes RJ Navickis WJ Sibbald 2001 Albumin versus hydroxyethyl starch in cardiopulmonary bypass surgery: a meta-analysis of postoperative bleeding Ann Thorac Surg 72 527 533 discussion 534
6. F Schortgen JC Lacherade F Bruneel I Cattaneo F Hemery F Lemaire L Brochard 2001 Effects of hydroxyethylstarch and gelatin on renal function in severe sepsis: a multicentre randomised study Lancet 357 911 916
7. E Pillebout D Nochy G Hill F Conti C Antoine Y Calmus D Glotz 2005 Renal histopathological lesions after orthotopic liver transplantation (OLT) Am J Transplant 5 1120 1129
8. K Bork 2005 Pruritus precipitated by hydroxyethyl starch: a review Br J Dermatol 152 3 12
9. A Sedrakyan K Gondek D Paltiel JA Elefteriades 2003 Volume expansion with albumin decreases mortality after coronary artery bypass graft surgery Chest 123 1853 1857
10. JJ Auwerda FW Leebeek JH Wilson OP van Diggelen KH Lam P Sonneveld 2006 Acquired lysosomal storage caused by frequent plasmapheresis procedures with hydroxyethyl starch Transfusion 46 1705 1711
11. FDA, Center for Biologics Evaluation and Research (2007) Product approval information - new drug applications. NDA review memo (mid-cycle) http://www.fda.gov/CbER/nda/voluven.htm. Accessed 10 Sept 2008
12. J Rudolf 2002 Hydroxyethyl starch for hypervolemic hemodilution in patients with acute ischemic stroke: a randomized, placebo-controlled phase II safety study Cerebrovasc Dis 14 33 41
13. FT Aichner F Fazekas M Brainin W Polz B Mamoli K Zeiler 1998 Hypervolemic hemodilution in acute ischemic stroke: the multicenter Austrian hemodilution stroke trial (MAHST) Stroke 29 743 749
14. E Klemm F Bepperling MA Burschka R Mosges 2007 Hemodilution therapy with hydroxyethyl starch solution (130/0.4) in unilateral idiopathic sudden sensorineural hearing loss: a dose-finding, double-blind, placebo-controlled, international multicenter trial with 210 patients Otol Neurotol 28 157 170
15. W Ganzevoort A Rep GJ Bonsel WP Fetter L van Sonderen JI De Vries H Wolf 2005 A randomised controlled trial comparing two temporising management strategies, one with and one without plasma volume expansion, for severe and early onset pre-eclampsia BJOG 112 1358 1368
16. D Ernest AS Belzberg PM Dodek 1999 Distribution of normal saline and 5% albumin infusions in septic patients Crit Care Med 27 46 50
17. AB Waxman N Ward T Thompson CM Lilly A Lisbon N Hill SA Nasraway S Heard H Corwin M Levy 2005 Roundtable debate: controversies in the management of the septic patient - desperately seeking consensus Crit Care 9 1
18. J Verheij A van Lingen PG Raijmakers ER Rijnsburger DP Veerman W Wisselink AR Girbes AB Groeneveld 2006 Effect of fluid loading with saline or colloids on pulmonary permeability, oedema and lung injury score after cardiac and major vascular surgery Br J Anaesth 96 21 30
19. ME Barron MM Wilkes RJ Navickis 2004 A systematic review of the comparative safety of colloids Arch Surg 139 552 563
20. J Avorn M Patel R Levin WC Winkelmayer 2003 Hetastarch and bleeding complications after coronary artery surgery Chest 124 1437 1442
21. AP Jonville-Bera E Autret-Leca Y Gruel 2001 Acquired type I von Willebrand's disease associated with highly substituted hydroxyethyl starch N Engl J Med 345 622 623
22. ML Cittanova I Leblanc C Legendre C Mouquet B Riou P Coriat 1996 Effect of hydroxyethylstarch in brain-dead kidney donors on renal function in kidney-transplant recipients Lancet 348 1620 1622
23. C Legendre E Thervet B Page A Percheron LH Noel H Kreis 1993 Hydroxyethylstarch and osmotic-nephrosis-like lesions in kidney transplantation Lancet 342 248 249
24. M Giral JP Bertola Y Foucher D Villers E Bironneau Y Blanloeil G Karam P Daguin L Lerat JP Soulillou 2007 Effect of brain-dead donor resuscitation on delayed graft function: results of a monocentric analysis Transplantation 83 1174 1181
25. Y Sakr D Payen K Reinhart FS Sipmann E Zavala J Bewley G Marx JL Vincent 2007 Effects of hydroxyethyl starch administration on renal function in critically ill patients Br J Anaesth 98 216 224
26. J Boldt M Lenz B Kumle M Papsdorf 1998 Volume replacement strategies on intensive care units: results from a postal survey Intensive Care Med 24 147 151
27. M Schmidt-Hieber C Loddenkemper S Schwartz G Arntz E Thiel M Notter 2006 Hydrops lysosomalis generalisatus - an underestimated side effect of hydroxyethyl starch therapy? Eur J Haematol 77 83 85
28. C Christidis F Mal J Ramos A Senejoux P Callard R Navarro JC Trinchet D Larrey M Beaugrand C Guettier 2001 Worsening of hepatic dysfunction as a consequence of repeated hydroxyethylstarch infusions J Hepatol 35 726 732
29. JJ Auwerda JH Wilson P Sonneveld 2002 Foamy macrophage syndrome due to hydroxyethyl starch replacement: a severe side effect in plasmapheresis Ann Intern Med 137 1013 1014
30. CC Trowbridge AH Stammers GC Wood JD Murdock M Klayman BR Yen E Woods C Gilbert 2005 Improved outcomes during cardiac surgery: a multifactorial enhancement of cardiopulmonary bypass techniques J Extra Corpor Technol 37 165 172
31. MY Tseng PJ Hutchinson PJ Kirkpatrick 2008 Effects of fluid therapy following aneurysmal subarachnoid haemorrhage: a prospective clinical study Br J Neurosurg 22 257 268
32. L Heilmann E Lorch B Hojnacki H Muntefering H Forster 1991 Accumulation of two different hydroxyethyl starch preparations in the placenta after hemodilution in patients with fetal intrauterine growth retardation or pregnancy hypertension Infusionstherapie 18 236 243
33. S Stander Z Szepfalusi B Bohle H Stander D Kraft TA Luger D Metze 2001 Differential storage of hydroxyethyl starch (HES) in the skin: an immunoelectron-microscopical long-term study Cell Tissue Res 304 261 269
34. TA Neff M Doelberg C Jungheinrich A Sauerland DR Spahn R Stocker 2003 Repetitive large-dose infusion of the novel hydroxyethyl starch 130/0.4 in patients with severe head injury Anesth Analg 96 1453 1459
35. SM Kasper P Meinert S Kampe C Gorg C Geisen U Mehlhorn C Diefenbach 2003 Large-dose hydroxyethyl starch 130/0.4 does not increase blood loss and transfusion requirements in coronary artery bypass surgery compared with hydroxyethyl starch 200/0.5 at recommended doses Anesthesiology 99 42 47
36. SA Kozek-Langenecker C Jungheinrich W Sauermann P Van der Linden 2008 The effects of hydroxyethyl starch 130/0.4 (6%) on blood loss and use of blood products in major surgery: a pooled analysis of randomized clinical trials Anesth Analg 107 382 390
37. J Boldt T Brenner A Lehmann J Lang B Kumle C Werling 2003 Influence of two different volume replacement regimens on renal function in elderly patients undergoing cardiac surgery: comparison of a new starch preparation with gelatin Intensive Care Med 29 763 769
38. C Jungheinrich R Scharpf M Wargenau F Bepperling JF Baron 2002 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 95 544 551
39. V Blasco M Leone F Antonini A Geissler J Albanese C Martin 2008 Comparison of the novel hydroxyethylstarch 130/0.4 and hydroxyethylstarch 200/0.6 in brain-dead donor resuscitation on renal function after transplantation Br J Anaesth 100 504 508
40. 14C-labelled hydroxyethyl starch (HES) 130/0.4 and HES 200/0.5 after repeated intravenous administration to rats Drugs R D 4 331 338
41. J Waitzinger F Bepperling G Pabst J Opitz 2003 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 4 149 157
42. J Boldt T Scholhorn J Mayer S Piper S Suttner 2006 The value of an albumin-based intravascular volume replacement strategy in elderly patients undergoing major abdominal surgery Anesth Analg 103 191 199
43. J Boldt C Brosch M Ducke M Papsdorf A Lehmann 2007 Influence of volume therapy with a modern hydroxyethylstarch preparation on kidney function in cardiac surgery patients with compromised renal function: a comparison with human albumin Critical Care Med 35 2740 2746
44. J Boldt M Ducke B Kumle M Papsdorf EL Zurmeyer 2004 Influence of different volume replacement strategies on inflammation and endothelial activation in the elderly undergoing major abdominal surgery Intensive Care Med 30 416 422
45. C Fenger-Eriksen C Hartig Rasmussen T Kappel Jensen E Anker-Moller J Heslop J Frokiaer E Tonnesen 2005 Renal effects of hypotensive anaesthesia in combination with acute normovolaemic haemodilution with hydroxyethyl starch 130/0.4 or isotonic saline Acta Anaesthesiol Scand 49 969 974
46. D Palumbo G Servillo L D'Amato ML Volpe G Capogrosso E De Robertis O Piazza R Tufano 2006 The effects of hydroxyethyl starch solution in critically ill patients Minerva Anestesiol 72 655 664
47. K Lang J Boldt S Suttner G Haisch 2001 Colloids versus crystalloids and tissue oxygen tension in patients undergoing major abdominal surgery Anesth Analg 93 405 409
48. K Lang S Suttner J Boldt B Kumle D Nagel 2003 Volume replacement with HES 130/0.4 may reduce the inflammatory response in patients undergoing major abdominal surgery Can J Anaesth 50 1009 1016