title: 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.
abstract: OBJECTIVE
  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.
  
  
  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.
mesh_terms: D000293:Adolescent; D000328:Adult; D016638:Critical Illness / Q000401:mortality*; D000077324:Crystalloid Solutions; D005260:Female; D005440:Fluid Therapy / Q000379:methods*; D006801:Humans; D006895:Hydroxyethyl Starch Derivatives / Q000008:administration & dosage* / Q000627:therapeutic use; D007362:Intensive Care Units; D007552:Isotonic Solutions / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D012151:Resuscitation / Q000379:methods*; D012965:Sodium Chloride / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D000077324:Crystalloid Solutions; D006895:Hydroxyethyl Starch Derivatives; D007552:Isotonic Solutions; D012965:Sodium Chloride