No results to report here, just a heads up that the CHEST study is underway: a randomised controlled trial of 7000 patients comparing of 6% hydroxyethyl starch (130/0.4) with 0.9% sodium chloride for all fluid resuscitation needs whilst in the intensive care unit (ICU). This is how the authors explain the rationale for the study:
Much of the evidence currently available to inform clinicians on the efficacy and safety of starch solutions for fluid resuscitation involves studies conducted using older, high molecular weight and high molar substitution starches. Meta-analyses of these studies suggest that when comparing starches to other fluids, the relative risk of mortality ranges from 1.00 (95% CI 0.80–1.25) to 1.35 (95% CI 0.94–1.95) and for kidney failure 1.50 (95% CI 1.20–1.87). There are insufficient data, however, on the newer low molecular weight, low molar substitution starches. To date, most published studies on these newer generation starches have been conducted in perioperative settings with small sample sizes and limited follow-up. They have been designed to examine surrogate outcomes and not important patient outcomes such as mortality or renal failure.
These are some of the same people who brought us the SAFE study on albumin and the NICE-SUGAR study on glycaemic control, so this will be one to watch. It is anticipated that recruitment will be completed by December 2011.
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.
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. 2011 May;37(5):816-823