• Journal of critical care · Jun 2012

    Randomized Controlled Trial Multicenter Study

    Fluid Resuscitation with 5% albumin versus Normal Saline in Early Septic Shock: a pilot randomized, controlled trial.

    • Lauralyn A McIntyre, Dean A Fergusson, Deborah J Cook, Brian H Rowe, Sean M Bagshaw, Dave Easton, Marcel Emond, Simon Finfer, Alison Fox-Robichaud, Claude Gaudert, Robert Green, Paul Hebert, John Marshall, Nigel Rankin, Ian Stiell, Alan Tinmouth, Joe Pagliarello, Alexis F Turgeon, Andrew Worster, Ryan Zarychanski, and Canadian Critical Care Trials Group.
    • Department of Medicine (Division of Critical Care), Ottawa Hospital Research Institute (OHRI), University of Ottawa,Ottawa, Ontario, Canada. lmcintyre@ottawahospital.on.ca
    • J Crit Care. 2012 Jun 1;27(3):317.e1-6.

    PurposeRandomized, controlled trials of fluid resuscitation in early septic shock face many logistic challenges. We describe the Fluid Resuscitation with 5% albumin versus Normal Saline in Early Septic Shock (PRECISE) pilot trial study design and report feasibility of patient recruitment.Materials And MethodsSix Canadian academic centers enrolled adult patients with early suspected septic shock from the emergency department and intensive care unit department. Consent was deferred. Using concealed allocation, participants were randomized to either 5% albumin or 0.9% sodium chloride. Blinded fluid resuscitation started immediately and continued for 7 days in the intensive care unit. Target recruitment was established a priori at 2 patients per site per month.ResultsFifty-one patients were enrolled; 50 patients received study fluid. We recruited a median of 2.5 patients (interquartile range [IQR], 1.5-3.0) per site per month into the trial. Median age and Acute Physiology and Chronic Health Evaluation II scores were 64.5 (IQR, 55.0-78.0) and 25.0 (IQR, 20.0-29.0), respectively. Most patients (n = 37 [74.0%]) were enrolled from the emergency department for a median of 1.6 hours (IQR, 0.8-3.5 hours) from their first hypotensive event and received a median of 2.4 L (IQR, 1.5-3.0 L) of resuscitation fluid before inclusion. Consent was deferred for 44 patients (89.8%).ConclusionsPatient recruitment into the PRECISE pilot trial met our prespecified feasibility targets, and the PRECISE team is planning the larger trial.Copyright © 2012 Elsevier Inc. All rights reserved.

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