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

John Myburgh, Rinaldo Bellomo, Alan Cass, Simon Finfer, Julie French, David Gattas, Parisa Glass, Joanne Lee, Jeffrey Lipman, Bette Liu, Colin McArthur, Shay McGuinness, Dorrilyn Rajbhandari, Colman Taylor, Steven Webb

    Research output: Contribution to journalArticle

    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.
    Original languageEnglish
    Pages (from-to)816-823
    Number of pages8
    JournalIntensive Care Medicine
    Volume37
    Issue number5
    DOIs
    Publication statusPublished - 2011

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