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Updated: May 4, 2026

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Hydroxyethyl starch in sepsis.

Nicolai Rosenkrantz Segelcke Haase1

  • 1Department of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark. nicolai.rosenkrantz.segelcke.haase@regionh.dk.

Danish Medical Journal
|January 8, 2014
PubMed
Summary
This summary is machine-generated.

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Tetrastarch, a hydroxyethyl starch (HES) fluid, was found to increase mortality and impair kidney function and hemostasis in critically ill patients. Regulatory agencies now recommend suspending HES marketing authorizations due to safety concerns.

Area of Science:

  • Critical Care Medicine
  • Nephrology
  • Pharmacology

Background:

  • Hydroxyethyl starch (HES) has been a common fluid resuscitation agent.
  • The newest generation, tetrastarch, was thought to be safer than older HES solutions.
  • Clinical evidence for tetrastarch's safety and efficacy was limited.

Purpose of the Study:

  • To assess the safety and efficacy of tetrastarch in a randomized clinical trial.
  • To systematically review existing randomized clinical trials on tetrastarch in sepsis patients.
  • To evaluate tetrastarch's impact on mortality, kidney function, and hemostasis.

Main Methods:

  • A blinded randomized clinical trial compared 6% HES 130/0.42 (tetrastarch) with Ringer's acetate in severe sepsis patients.
  • Primary outcome was 90-day death or dialysis dependency.

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  • A systematic review and meta-analysis of randomized trials comparing tetrastarch with crystalloids or albumin in sepsis patients were conducted.

    • Main Results:

    • Tetrastarch was associated with a higher 90-day mortality rate (51% vs. 43%) and increased need for renal replacement therapy (22% vs. 16%).
    • Severe bleeding events were more frequent in the tetrastarch group (10% vs. 6%).
    • Meta-analyses of nine trials (3,456 patients) showed increased renal replacement therapy, red blood cell use, and serious adverse events with tetrastarch.

    Conclusions:

    • Tetrastarch impairs kidney function and hemostasis and may increase mortality in critically ill patients.
    • Evidence suggests potential harm across various patient groups, with no identified overall benefit.
    • European regulatory bodies recommend suspending marketing authorizations for all HES solutions.