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The Crystalloid versus Hydroxyethyl Starch Trial: protocol for a multi-centre randomised controlled trial of fluid resuscitation with 6% hydroxyethyl starch (130/0.4) compared to 0.9% sodium chloride (saline) in intensive care patients on mortality

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Abstract

Purpose

The intravenous fluid 6% hydroxyethyl starch (130/0.4) (6% HES 130/0.4) is used widely for resuscitation but there is limited information on its efficacy and safety. A large-scale multi-centre randomised controlled trial (CHEST) in critically ill patients is currently underway comparing fluid resuscitation with 6% HES 130/0.4 to 0.9% sodium chloride on 90-day mortality and other clinically relevant outcomes including renal injury. This report describes the study protocol.

Methods

CHEST will recruit 7,000 patients to concealed, random, parallel assignment of either 6% HES 130/0.4 or 0.9% sodium chloride for all fluid resuscitation needs whilst in the intensive care unit (ICU). The primary outcome will be all-cause mortality at 90 days post-randomisation. Secondary outcomes will include incident renal injury, other organ failures, ICU and hospital mortality, length of ICU stay, quality of life at 6 months, health economic analyses and in patients with traumatic brain injury, functional outcome. Subgroup analyses will be conducted in four predefined subgroups. All analyses will be conducted on an intention-to-treat basis.

Results and conclusions

The study run-in phase has been completed and the main trial commenced in April 2010. CHEST should generate results that will inform and influence prescribing of this commonly used resuscitation fluid.

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Authors and Affiliations

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    The Crystalloid versus Hydroxyethyl Starch Trial (CHEST) Management Committee

    Additional information

    Members of the Crystalloid versus Hydroxyethyl Starch Trial (CHEST) Management Committee are listed in the Appendix.

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    Supplementary material 1 (DOC 324 kb)

    Appendix: Crystalloid versus Hydroxyethyl Starch Trial (CHEST) Management Committee

    Appendix: Crystalloid versus Hydroxyethyl Starch Trial (CHEST) Management Committee

    John Myburgh (Chair, George Institute, University of New South Wales, St George Hospital, Sydney), Rinaldo Bellomo (George Institute, University of Melbourne, Austin Hospital, Melbourne), Alan Cass (George Institute, University of Sydney), Simon Finfer (George Institute, University of Sydney, Royal North Shore Hospital, Sydney), Julie French (Project Manager, George Institute), David Gattas (Royal Prince Alfred Hospital, Sydney), Parisa Glass (George Institute), Joanne Lee (George Institute), Jeffrey Lipman (University Queensland, Royal Brisbane and Women’s Hospital) , Bette Liu (George Institute, University of Sydney) , Colin McArthur (Australian and New Zealand Intensive Care Society Clinical Trials Group), Shay McGuinness (Auckland Cardiovascular Hospital, New Zealand), Dorrilyn Rajbhandari (George Institute), Colman Taylor (George Institute, University of Sydney), Steve Webb (Australian and New Zealand Intensive Care Society Clinical Trials Group).

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    The Crystalloid versus Hydroxyethyl Starch Trial (CHEST) Management Committee. The Crystalloid versus Hydroxyethyl Starch Trial: protocol for a multi-centre randomised controlled trial of fluid resuscitation with 6% hydroxyethyl starch (130/0.4) compared to 0.9% sodium chloride (saline) in intensive care patients on mortality. Intensive Care Med 37, 816–823 (2011). https://doi.org/10.1007/s00134-010-2117-9

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    • DOI: https://doi.org/10.1007/s00134-010-2117-9

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