02506nas a2200373   4500000000100000008004100001260001700042100001600059700001700075700001200092700001400104700001300118700002100131700001500152700001300167700001400180700001400194700001400208700001600222700001900238700001500257700001500272700001900287700001700306700001200323700001500335700001600350245012100366250001500487300001300502490000700515520156400522020004602086       2012                            d  c-357263871641 aMcIntyre L.1 aFergusson D.1 aRowe B.1 aEaston D.1 aEmond M.1 aFox-Robichaud A.1 aGaudert C.1 aGreen R.1 aHebert P.1 aRankin N.1 aStiell I.1 aTinmouth A.1 aPagliarello J.1 aTurgeon A.1 aWorster A.1 aZarychanski R.1 aFinfer Simon1 aCook D.1 aBagshaw S.1 aMarshall J.00aFluid Resuscitation with 5% albumin versus Normal Saline in Early Septic Shock: a pilot randomized, controlled trial  a2011/12/20  a317 e1-60 v273 a<p>
PURPOSE: Randomized, 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 METHODS: Six 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. RESULTS: Fifty-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%). CONCLUSIONS: Patient recruitment into the PRECISE pilot trial met our prespecified feasibility targets, and the PRECISE team is planning the larger trial.
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