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01-02-2014 | What's New in Intensive Care

Hydroxyethyl starch: putting patient safety first

Authors: Julian Bion, Rinaldo Bellomo, John Myburgh, Anders Perner, Konrad Reinhart, Simon Finfer

Published in: Intensive Care Medicine | Issue 2/2014

Excerpt

In November 2012 the European Medicines Agency (EMA) received a request to examine the risks and benefits of intravenous fluids containing hydroxyethyl starch (HES). The main concerns were that the administration of HES was associated with a number of harmful effects, most notably an increased risk of kidney injury [1‐5] and an increased risk of death [6, 7], particularly in critically ill patients and patients with sepsis. …

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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 39:558–568PubMedCrossRef

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 367:1901–1911PubMedCrossRef

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 346:839CrossRef

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 367:124–134PubMedCrossRef

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 309:678–688PubMedCrossRef

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

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.

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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 345:622–623PubMedCrossRef

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 37:1725–1737PubMedCrossRef

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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 138:703–711PubMedCrossRef

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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 144:223–230PubMedCrossRef

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 PubMed

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 107:693–702PubMedCrossRef

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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

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Bellomo R, Bion J, Finfer S, Myburgh J, Perner A, Reinhart K (2013) Open Letter. Brit J Anaesth (in press)

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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):R94PubMedCrossRef

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Title: Hydroxyethyl starch: putting patient safety first
Authors: Julian Bion
Rinaldo Bellomo
John Myburgh
Anders Perner
Konrad Reinhart
Simon Finfer
Publication date: 01-02-2014
Publisher: Springer Berlin Heidelberg
Published in: Intensive Care Medicine / Issue 2/2014
Print ISSN: 0342-4642
Electronic ISSN: 1432-1238
DOI: https://doi.org/10.1007/s00134-013-3167-6

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