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Hydroxyethyl starch: putting patient safety first

Julian Bion| Rinaldo Bellomo| John Myburgh| Anders Perner| Konrad Reinhart| Simon Finfer
What's New in Intensive Care
Volume 40, Issue 2 / February , 2014

Pages 256 - 259

No abstract available.

References

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  2. Brunkhorst FM, Engel C, Bloos F, Meier-Hellmann A, Ragaller M, Weiler N, Moerer O, Gruendling M, Oppert M, Grond S, Olthoff D, Jaschinski U, John S, Rossaint R, Welte T, Schaefer M, Kern P, Kuhnt E, Kiehntopf M, Hartog C, Natanson C, Loeffler M, Reinhart K (2008) Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med 358:125–139
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  3. Gattas DJ, Dan A, Myburgh J, Billot L, Lo S, Finfer S (2013) Fluid resuscitation with 6 % hydroxyethyl starch (130/0.4 and 130/0.42) in acutely ill patients: systematic review of effects on mortality and treatment with renal replacement therapy. Intensive Care Med 39:558–568
  4. Myburgh JA, Finfer S, Bellomo R, Billot L, Cass A, Gattas D, Glass P, Lipman J, Liu B, McArthur C, McGuinness S, Rajbhandari D, Taylor CB, Webb SA (2012) Hydroxyethyl starch or saline for fluid resuscitation in intensive care. N Engl J Med 367:1901–1911
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  5. Haase N, Perner A, Hennings LI, Siegemund M, Lauridsen B, Wetterslev M, Wetterslev J (2013) Hydroxyethyl starch 130/0.38–0.45 versus crystalloid or albumin in patients with sepsis: systematic review with meta-analysis and trial sequential analysis. BMJ 346:839
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  6. Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Aneman A, Madsen KR, Moller MH, Elkjaer JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Soe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjaeldgaard AL, Fabritius ML, Mondrup F, Pott FC, Moller TP, Winkel P, Wetterslev J (2012) Hydroxyethyl starch 130/0.42 versus Ringer’s acetate in severe sepsis. N Engl J Med 367:124–134
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  7. Zarychanski R, Abou-Setta AM, Turgeon AF, Houston BL, McIntyre L, Marshall JC, Fergusson DA (2013) Association of hydroxyethyl starch administration with mortality and acute kidney injury in critically ill patients requiring volume resuscitation: a systematic review and meta-analysis. JAMA 309:678–688
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  8. European Medicines Agency (EMA) (2013) Press release: European Medicines Agency (EMA) PRAC recommends suspending marketing authorisations for infusion solutions containing hydroxyethyl-starch. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/06/news_detail_001814.jsp&mid=WC0b01ac058004d5c1. Accessed 12 Nov 2013
  9. European Medicines Agency (EMA) (2013) Press Release: European Medicines Agency (EMA) PRAC confirms that hydroxyethyl-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Solutions_for_infusion_containing_hydroxyethyl_starch/Recommendation_provided_by_Pharmacovigilance_Risk_Assessment_Committee/WC500151963.pdf. Accessed 12 Nov 2013
  10. European Medicines Agency (EMA) (2013) Press Release: Hydroxyethyl-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients—CMDh endorses PRAC recommendations. EMA/640658/2013. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/10/news_detail_001930.jsp&mid=WC0b01ac058004d5c1. Accessed 12 Nov 2013
  11. Annane D, Siami S, Jaber S, Martin C, Elatrous S, Declere AD, Preiser JC, Outin H, Troche G, Charpentier C, Trouillet JL, Kimmoun A, Forceville X, Darmon M, Lesur O, Regnier J, Abroug F, Berger P, Clech C, Cousson J, Thibault L, Chevret S, for the CI (2013) Effects of fluid resuscitation with colloids vs crystalloids on mortality in critically ill patients presenting with hypovolemic shock: the CRISTAL randomized trial. JAMA 310:1809–1817. doi:10.1001/jama.2013.280502
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  12. Ludwig-Maximilians–University of Munich (2010) Klinisches Register RaftinG—Rational Fluid Therapy in Germany (Protocol). Available at: http://clinicaltrials.gov/show/NCT01122277
  13. University Hospital, Basel, Switzerland (2006) Basel Study for Evaluation of Starch (130; 0.4) Infusion in Septic Patients: BaSES (130; 0.4) Trial (Protocol). Available at: http://www.clinicaltrials.gov/ct2/show/NCT00273728
  14. Jonville-Bera AP, Autret-Leca E, Gruel Y (2001) Acquired type I von Willebrand’s disease associated with highly substituted hydroxyethyl starch. N Engl J Med 345:622–623
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  15. Hartog CS, Reuter D, Loesche W, Hofmann M, Reinhart K (2011) Influence of hydroxyethyl starch (HES) 130/0.4 on hemostasis as measured by viscoelastic device analysis: a systematic review. Intensive Care Med 37:1725–1737
  16. Hecht-Dolnik M, Barkan H, Taharka A, Loftus J (2009) Hetastarch increases the risk of bleeding complications in patients after off-pump coronary bypass surgery: a randomized clinical trial. J Thorac Cardiovasc Surg 138:703–711
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  17. Mittermayr M, Streif W, Haas T, Fries D, Velik-Salchner C, Klingler A, Oswald E, Bach C, Schnapka-Koepf M, Innerhofer P (2007) Hemostatic changes after crystalloid or colloid fluid administration during major orthopedic surgery: the role of fibrinogen administration. Anesth Analg 105:905–917
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  18. Navickis RJ, Haynes GR, Wilkes MM (2012) Effect of hydroxyethyl starch on bleeding after cardiopulmonary bypass: a meta-analysis of randomized trials. J Thorac Cardiovasc Surg 144:223–230
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  19. Rasmussen KC, Johansson PI, Hojskov M, Kridina I, Kistorp T, Thind P, Nielsen HB, Ruhnau B, Pedersen T, Secher NH (2013) Hydroxyethyl starch reduces coagulation competence and increases blood loss during major surgery: results from a randomized controlled trial. Ann Surg. doi:10.1097/SLA.0000000000000267
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  20. James MF, Michell WL, Joubert IA, Nicol AJ, Navsaria PH, Gillespie RS (2011) Resuscitation with hydroxyethyl starch improves renal function and lactate clearance in penetrating trauma in a randomized controlled study: the FIRST trial (fluids in resuscitation of severe trauma). Br J Anaesth 107:693–702
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  21. Haase N, Wetterslev J, Winkel P, Perner A (2013) Bleeding and risk of death with hydroxyethyl starch in severe sepsis: post hoc analyses of a randomized clinical trial. Intensive Care Med. doi:10.1007/s00134-013-3111-9
  22. Bellomo R, Bion J, Finfer S, Myburgh J, Perner A, Reinhart K (2013) Open Letter. Brit J Anaesth (in press)
  23. Bellomo R, Bion J, Finfer S, Myburgh J, Perner A, Reinhart K (2013) Open Letter. Acta Scand Anaesthesiol (in press)
  24. Guidet B, Martinet O, Boulain T, Philippart F, Poussel JF, Maizel J, Forceville X, Feissel M, Hasselmann M, Heininger A, Van Aken H (2012) Assessment of hemodynamic efficacy and safety of 6 % hydroxyethylstarch 130/0.4 vs. 0.9 % NaCl fluid replacement in patients with severe sepsis: the CRYSTMAS study. Crit Care 16(3):R94
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  25. Hartog CS, Reinhart K (2012) CRYSTMAS study adds to concerns about renal safety and increased mortality in sepsis patients. Crit Care 16(6):454. http://ccforum.com/content/16/6/454
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