title: Fluid Resuscitation with 5% albumin versus Normal Saline in Early Septic Shock: a pilot randomized, controlled trial.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Department of Medicine (Division of Critical Care), Ottawa Hospital Research Institute (OHRI), University of Ottawa,Ottawa, Ontario, Canada. lmcintyre@ottawahospital.on.ca
authors.forename: Lauralyn A
authors.initials: LA
authors.lastname: McIntyre
authors.forename: Dean A
authors.initials: DA
authors.lastname: Fergusson
authors.forename: Deborah J
authors.initials: DJ
authors.lastname: Cook
authors.forename: Brian H
authors.initials: BH
authors.lastname: Rowe
authors.forename: Sean M
authors.initials: SM
authors.lastname: Bagshaw
authors.forename: Dave
authors.initials: D
authors.lastname: Easton
authors.forename: Marcel
authors.initials: M
authors.lastname: Emond
authors.forename: Simon
authors.initials: S
authors.lastname: Finfer
authors.forename: Alison
authors.initials: A
authors.lastname: Fox-Robichaud
authors.forename: Claude
authors.initials: C
authors.lastname: Gaudert
authors.forename: Robert
authors.initials: R
authors.lastname: Green
authors.forename: Paul
authors.initials: P
authors.lastname: Hebert
authors.forename: John
authors.initials: J
authors.lastname: Marshall
authors.forename: Nigel
authors.initials: N
authors.lastname: Rankin
authors.forename: Ian
authors.initials: I
authors.lastname: Stiell
authors.forename: Alan
authors.initials: A
authors.lastname: Tinmouth
authors.forename: Joe
authors.initials: J
authors.lastname: Pagliarello
authors.forename: Alexis F
authors.initials: AF
authors.lastname: Turgeon
authors.forename: Andrew
authors.initials: A
authors.lastname: Worster
authors.forename: Ryan
authors.initials: R
authors.lastname: Zarychanski
mesh_terms: D000368:Aged; D004311:Double-Blind Method; D005240:Feasibility Studies; D005260:Female; D005440:Fluid Therapy / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D010865:Pilot Projects; D012709:Serum Albumin / Q000627:therapeutic use*; D012772:Shock, Septic / Q000628:therapy*; D012965:Sodium Chloride / Q000627:therapeutic use
chemical_list: D012709:Serum Albumin; D012965:Sodium Chloride