• Lauralyn McIntyre, Dean A Fergusson, Brian Rowe, Deborah J Cook, Yaseen Arabi, Sean M Bagshaw, Marcel Emond, Simon Finfer, Alison Fox-Robichaud, Alasdair Gray, Robert Green, Paul Hebert, Eddy Lang, John Marshall, Ian Stiell, Alan Tinmouth, Joe Pagliarello, Alexis Turgeon, Timothy Walsh, Andrew Worster, Ryan Zarychanski, and Canadian Critical Care Trials Group.
• The Clinical Epidemiology Program, Ottawa Hospital Research Institute (OHRI), The Ottawa Hospital, Ottawa, Ontario, Canada. lmcintyre@toh.on.ca
• Transfus Med Rev. 2012 Oct 1;26(4):333-41.

AbstractSevere sepsis and septic shock are the most common reasons for admission to an intensive care unit; and the risk of death is substantial, estimated at approximately 40%. Evidence suggests that early resuscitation strategies that include the use of resuscitation fluids, antibiotics, blood, and inotropes reduce death. Although fluid resuscitation is an immediate life-saving intervention, a fundamental question that remains unanswered is whether the type of resuscitation fluid impacts survival when it is initiated very early in the course of septic shock. A randomized controlled trial published in 2008 confirmed that hydroxyethyl starch fluids cause acute renal failure defined by the requirement for renal replacement therapy. In contrast, a subgroup analysis from a randomized controlled trial suggests that 4% albumin fluid may reduce death from severe sepsis; however, these findings require confirmation in a large randomized trial. Our team is planning a pragmatic early septic shock fluid resuscitation trial that will compare the effectiveness of 5% albumin vs normal saline on 90-day mortality (PRECISE). In this article, we summarize the scientific rationale and inherent challenges associated with the conduct of PRECISE, the background work and planning elements that have been undertaken, and the PRECISE RCT protocol with rationale and justifications provided for the chosen population, the interventions, and the outcome measures.Copyright © 2012 Elsevier Inc. All rights reserved.

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