02341nas a2200313   4500000000100000008004100001100001800042700000500060700001400065700001200079700001400091700001700105700001400122700001600136700001800152700001900170700001400189700001400203700001500217700001700232700002000249700003500269245025300304250001500557300001100572490000700583520139100590020004601981       2011                            d1 aTaylor Colman1 a1 aLipman J.1 aWebb S.1 aGattas D.1 aGlass Parisa1 aLiu Bette1 aMcArthur C.1 aMcGuinness S.1 aRajbhandari D.1 aFrench J.1 aCass Alan1 aLee Joanne1 aFinfer Simon1 aBellomo Rinaldo1 aThe CHEST Management Committee00aThe 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  a2011/02/11  a816-230 v373 a<p>
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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