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Intensive Care Medicine

, Volume 37, Issue 5, pp 816–823 | Cite as

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

  • The Crystalloid versus Hydroxyethyl Starch Trial (CHEST) Management CommitteeEmail author
Original

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.

Keywords

Hydroxyethyl starch Fluid therapy Resuscitation Colloids Randomised controlled trials 

Supplementary material

134_2010_2117_MOESM1_ESM.doc (324 kb)
Supplementary material 1 (DOC 324 kb)

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Copyright information

© Copyright jointly held by Springer and ESICM 2011

Authors and Affiliations

  • The Crystalloid versus Hydroxyethyl Starch Trial (CHEST) Management Committee
    • 1
    Email author
  1. 1.Critical Care and Trauma DivisionThe George Institute for International HealthSydneyAustralia

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