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Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine

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Open Access 01-12-2013 | Letter to the Editor

Debate on HES safety is important, but must be based on facts

Authors: Nicolai Haase, Rasmus Müller, Anders Perner

Published in: Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine | Issue 1/2013

Abstract

The Scandinavian Starch for Severe Sepsis / Septic Shock (6S) trial showed that hydroxyethyl starch was harmful compared to Ringer’s acetate in patients with severe sepsis when used according to clinical practice and in alignment with the recommendations by the manufactures and authorities. The different interpretation by Chapell and Jacob’s rely on misreading of the trial publication and is not supported by the trial data. Several hypotheses may be made regarding less harmful ways of using HES in critically ill patients, but clinicians, guideline committee members and authorities need to acknowledge that such safer ways have not yet been identified.

Chappell D, Jacob M: Hydroxyethyl starch - the importance of being earnest. Scand J Trauma Resusc Emerg Med. 2013, 61: 21-

Haase N, Perner A, Hennings LI, Siegemund M, Lauridsen B, Wetterslev M, Wetterslev J: 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. 2013, 346: f839-10.1136/bmj.f839.PubMedCentralCrossRefPubMed

Gattas DJ, Dan A, Myburgh J, Billot L, Lo S, Finfer S: 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. 2013, 39: 558-568. 10.1007/s00134-013-2840-0.CrossRefPubMed

Patel A, Waheed U, Brett SJ: Randomised trials of 6% tetrastarch (hydroxyethyl starch 130/0.4 or 0.42) for severe sepsis reporting mortality: systematic review and meta-analysis. Intensive Care Med. 2013, 39: 811-822. 10.1007/s00134-013-2863-6.CrossRefPubMed

Perel P, Roberts I, Ker K: Colloids versus crystalloids for fluid resuscitation in critically ill patients. Cochrane Database Syst Rev. 2013, 2: CD000567

Mutter TC, Ruth CA, Dart AB: Hydroxyethyl starch (HES) versus other fluid therapies: effects on kidney function. Cochrane DB Syst Rev. 2013, 7: CD007594

Zarychanski R, Abou-Setta AM, Turgeon AF, Houston BL, McIntyre L, Marshall JC, Fergusson DA: 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. 2013, 309: 678-688. 10.1001/jama.2013.430.CrossRefPubMed

FDA Safety Communication: Boxed Warning on increased mortality and severe renal injury, and additional warning on risk of bleeding, for use of hydroxyethyl starch solutions in some settings.http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm358271.htm,

PRAC recommends suspending marketing authorisations for infusion solutions containing hydroxyethyl-starch. 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/WC500144448.pdf]

10.

Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Åneman A, Madsen KR, Møller MH, Elkjær JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Søe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjældgaard A-L, Fabritius ML, Mondrup F, Pott FC, Møller TP: Hydroxyethyl starch 130/0.42 versus Ringer’s acetate in severe sepsis. N Engl J Med. 2012, 367: 124-134. 10.1056/NEJMoa1204242.CrossRefPubMed

11.

Perner A, Haase N, Wetterslev J, Aneman A, Tenhunen J, Guttormsen AB, Klemenzson G, Pott F, Bødker KD, Bådstøløkken PM, Bendtsen A, Søe-Jensen P, Tousi H, Bestle M, Pawlowicz M, Winding R, Bülow H-H, Kancir C, Steensen M, Nielsen J, Fogh B, Madsen KR, Larsen NH, Carlsson M, Wiis J, Petersen JA, Iversen S, Schøidt O, Leivdal S, Berezowicz P: Comparing the effect of hydroxyethyl starch 130/0.4 with balanced crystalloid solution on mortality and kidney failure in patients with severe sepsis (6S--Scandinavian Starch for Severe Sepsis/Septic Shock trial): study protocol, design and rationale for. Trials. 2011, 12: 24-10.1186/1745-6215-12-24.PubMedCentralCrossRefPubMed

Title: Debate on HES safety is important, but must be based on facts
Authors: Nicolai Haase
Rasmus Müller
Anders Perner
Publication date: 01-12-2013
Publisher: BioMed Central
Published in: Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine / Issue 1/2013
Electronic ISSN: 1757-7241
DOI: https://doi.org/10.1186/1757-7241-21-66

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