@article{16800, author = {Fergusson D. and Emond M. and Fox-Robichaud A. and Green R. and Hebert P. and Stiell I. and Tinmouth A. and Pagliarello J. and Worster A. and Zarychanski R. and Finfer Simon and McIntyre L. and Rowe B. and Arabi Y. and Gray A. and Lang E. and Turgeon A. and Walsh T. and Canadian Critical Care Trials Group and Cook D. and Bagshaw S. and Marshall J.}, title = {The PRECISE RCT: Evolution of an Early Septic Shock Fluid Resuscitation Trial}, abstract = {

Severe 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.

}, year = {2012}, journal = {Transfusion Medicine Reviews}, edition = {2012/01/10}, isbn = {1532-9496 (Electronic)0887-7963 (Linking)}, note = {for the Canadian Critical Care Trials GroupTransfusion medicine reviewsTransfus Med Rev. 2012 Jan 4.}, language = {Eng}, }