References
Schortgen F, Lacherade JC, Bruneel F, Cattaneo I, Hemery F, Lemaire F, Brochard L (2001) Effects of hydroxyethylstarch and gelatin on renal function in severe sepsis: a multicentre randomised study. Lancet 357:911–916
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
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
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
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
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
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
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
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
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
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
Ludwig-Maximilians–University of Munich (2010) Klinisches Register RaftinG—Rational Fluid Therapy in Germany (Protocol). Available at: http://clinicaltrials.gov/show/NCT01122277
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
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
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
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
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
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
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
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
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
Bellomo R, Bion J, Finfer S, Myburgh J, Perner A, Reinhart K (2013) Open Letter. Brit J Anaesth (in press)
Bellomo R, Bion J, Finfer S, Myburgh J, Perner A, Reinhart K (2013) Open Letter. Acta Scand Anaesthesiol (in press)
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
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
Conflicts of interest
J Bion: Chair of Data Safety Monitoring Board for International Study of Dexmedetomidine for Orion 2008–2009; honoraria paid to hospital charity. Member of scientific advisory board for Nestle; honoraria (if any) to be paid to hospital charity. Research grants from Health Foundation; NIHR Health Services Research & Delivery Programme; NIHR Research for patient Benefit Programme; EU Leonardo Programme.
R Bellomo: Consultancy fees from Gambro, Baxter and Philips Medical.
John Myburgh: Travel support vian The George Institute for Global Health, Sydney, Australia, this author’s institution, from Fresenius Kabi in relation to the development and conduct of an investigator-initiated randomised-controlled trial (the Crystalloid vs. Hydroxyethyl Starch Trial) and travel expenses and honoraria from Baxter in relation to participation on advisory boards.
Anders Perner: Funding for research from Fresenius Kabi, B Braun AG, CSL Behring, Cosmed and BioPorto A/S. Speakers fee from LBP SA.
Konrad Reinhart: Unpaid Chairman of the Global Sepsis Alliance. B Braun AG and CSL Behring are sponsors of the Global Sepsis Alliance and of World Sepsis Day.
Simon Finfer: Travel support and grant support to his institution (The George Institute for Global Health through the University of Sydney) from Fresenius Kabi, and travel support and advisory fees to his institution (The George Institute for Global Health) from Baxter and CSL Behring.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Bion, J., Bellomo, R., Myburgh, J. et al. Hydroxyethyl starch: putting patient safety first. Intensive Care Med 40, 256–259 (2014). https://doi.org/10.1007/s00134-013-3167-6
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00134-013-3167-6