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Critical Care

, 17:452 | Cite as

Patient-centered outcomes and trials of hydroxyethyl starch

  • John Myburgh
  • Simon Finfer
  • Rinaldo Bellomo
Open Access
Letter

Keywords

Starch Renal Replacement Therapy Insulin Therapy Institutional Ethic Committee Hydroxyethyl 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Abbreviations

CHEST

Crystalloid vs. Hydroxyethyl Starch Trial

HES

Hydroxyethyl starch.

Meybohm and colleagues [1] propose that hydroxyethyl starch (HES) may be used safely in hypovolemicpatients by applying a clinical algorithm and by restricting the doseadministered.

The authors question the validity of the results of the two trials that constituteover 60% of current data [2, 3] and misleadingly state that in the Crystalloid vs. Hydroxyethyl StarchTrial (CHEST), HES administration did not increase the use of renal replacementtherapy by referring to the adjusted analyses that were published in the electronicsupplement [2]. The unadjusted analysis was pre-specified as the principal outcomemeasure and is the appropriate measure to influence clinical practice. The authorsalso ignore the consistent signal of harm associated with HES, specificallyincreased mortality and use of renal replacement therapy that is evident despitewide variations in aggregate doses of HES in the three major clinical trials: 70ml/kg in the Efficacy of Volume Substitution and Insulin Therapy in Severe Sepsistrial [4], 44 ml/kg in the Scandinavian Starch for Severe Sepsis/Septic Shock study [3], and 5 ml/kg in CHEST. Meybohm and colleagues make no comment thatadverse effects of HES represent an overall toxic effect caused by increased tissueaccumulation that is recognised as a dose-dependent, generic HES effect [5].

The ‘presumably correct indication’ and the algorithm they propose havenot been validated nor are they supported by any credible clinical evidence. Theirproposed algorithm and target population must be evaluated in rigorously conductedrandomized controlled trials before being considered for adoption into clinicalpractice. Given the consistent evidence that HES is nephrotoxic and may increasemortality [6], it is doubtful that institutional ethics committees would approve such atrial, or that informed patients would consent to participate.

Notes

References

  1. 1.
    Meybohm P, Van Aken H, De Gasperi A, De Hert S, Della Rocca G, Girbes AR, Gombotz H, Guidet B, Hasibeder W, Hollmann MW, Ince C, Jacob M, Kranke P, Kozek-Langenecker S, Loer SA, Martin CD, Siegemund M, Wunder C, Zacharowski K: Re-evaluating currently available data and suggestions for planningrandomised controlled studies regarding the use of hydroxyethyl-starch incritically ill patients - a multidisciplinary statement. Crit Care 2013, 17: R166. 10.1186/cc12845PubMedCentralCrossRefPubMedGoogle Scholar
  2. 2.
    Myburgh JA, Finfer S, Bellomo R, Billot L, Cass A, Gattas D, Glass P, Lipman J, Liu B, McArthur C, McgGuinness S, Rajbhandari D, Taylor CB, Webb SAR, the CHEST Investigators and the Australian and New Zealand IntensiveCare Society Clinical Trials Group: Hydroxyethyl starch or saline for fluid resuscitation in intensive care. N Engl J Med 2012, 367: 1901-1911. 10.1056/NEJMoa1209759CrossRefPubMedGoogle Scholar
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  4. 4.
    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, German Competence Network Sepsis (SepNet): Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med 2008, 358: 125-139. 10.1056/NEJMoa070716CrossRefPubMedGoogle Scholar
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    Bellmann R, Feistritzer C, Wiedermann CJ: Effect of molecular weight and substitution on tissue uptake of hydroxyethylstarch: a meta-analysis of clinical studies. Clin Pharmacokinet 2012, 51: 225-236. 10.2165/11594700-000000000-00000CrossRefPubMedGoogle Scholar
  6. 6.
    Mutter TC, Ruth CA, Dart AB: Hydroxyethyl starch (HES) versus other fluid therapies: effects on kidneyfunction. Cochrane Database Syst Rev 2013, 7:-CD007594.Google Scholar

Copyright information

© BioMed Central Ltd. 2013

Authors and Affiliations

  • John Myburgh
    • 1
    • 2
  • Simon Finfer
    • 1
    • 3
  • Rinaldo Bellomo
    • 1
    • 4
  1. 1.The George Institute for Global Health,SydneyAustralia
  2. 2.St George Clinical School University of New South WalesSydneyAustralia
  3. 3.Royal North Shore Hospital University of Sydney,St Leonards SydneyAustralia
  4. 4.Austin Hospital University of MelbourneHeidelberg MelbourneAustralia

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