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.
AD - Department of Medicine (Division of Critical Care), Ottawa Hospital Research Institute (OHRI), University of Ottawa,Ottawa, Ontario, Canada. lmcintyre@ottawahospital.on.ca AN - 22176806 BT - Journal of Critical Care DA - -35726387164 DP - NLM ET - 2011/12/20 LA - eng M1 - 3 N1 - McIntyre, Lauralyn AFergusson, Dean ACook, Deborah JRowe, Brian HBagshaw, Sean MEaston, DaveEmond, MarcelFinfer, SimonFox-Robichaud, AlisonGaudert, ClaudeGreen, RobertHebert, PaulMarshall, JohnRankin, NigelStiell, IanTinmouth, AlanPagliarello, JoeTurgeon, Alexis FWorster, AndrewZarychanski, RyanCanadian Critical Care Trials GroupResearch Support, Non-U.S. Gov'tUnited StatesJ Crit Care. 2012 Jun;27(3):317.e1-6. Epub 2011 Dec 15. N2 -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.
PY - 2012 SN - 1557-8615 (Electronic)0883-9441 (Linking) SP - 317 e1 EP - 6 T2 - Journal of Critical Care TI - Fluid Resuscitation with 5% albumin versus Normal Saline in Early Septic Shock: a pilot randomized, controlled trial VL - 27 ER -