BACKGROUND: Fluid and vasopressor management in septic shock remains controversial. In this randomized controlled trial, we evaluated the efficacy of dynamic measures (stroke volume change during passive leg raise) to guide resuscitation and improve patient outcome. RESEARCH QUESTION: Will resuscitation that is guided by dynamic assessments of fluid responsiveness in patients with septic shock improve patient outcomes? STUDY DESIGN AND METHODS: We conducted a prospective, multicenter, randomized clinical trial at 13 hospitals in the United States and United Kingdom. Patients presented to EDs with sepsis that was associated hypotension and anticipated ICU admission. Intervention arm patients were assessed for fluid responsiveness before clinically driven fluid bolus or increase in vasopressors occurred. The protocol included reassessment and therapy as indicated by the passive leg raise result. The control arm received usual care. The primary clinical outcome was positive fluid balance at 72 hours or ICU discharge, whichever occurred first. RESULTS: In modified intent-to-treat analysis that included 83 intervention and 41 usual care eligible patients, fluid balance at 72 hours or ICU discharge was significantly lower (À1.37 L favoring the intervention arm; 0.65 AE 2.85 L intervention arm vs 2.02 AE 3.44 L usual care arm; P ¼ .021. Fewer patients required renal replacement therapy (5.1% vs 17.5%; P ¼ .04) or mechanical ventilation (17.7% vs 34.1%; P ¼ .04) in the intervention arm compared with usual care. In the all-randomized intent-to-treat population (102 intervention, 48 usual care), there were no significant differences in safety signals. INTERPRETATION: Physiologically informed fluid and vasopressor resuscitation with the use of the passive leg raise-induced stroke volume change to guide management of septic shock is safe and demonstrated lower net fluid balance and reductions in the risk of renal and respiratory failure. Dynamic assessments to guide fluid administration may improve outcomes for patients with septic shock compared with usual care.

Objective: It is unclear if a low or high-volume intravenous (IV) fluid resuscitation strategy is better for patients with severe sepsis and septic shock. Design: Prospective randomized controlled trial. Setting: Two adult acute care hospitals within a single academic system. Patients: Patients with severe sepsis and septic shock admitted from the emergency department to the intensive care unit (ICU) from November 2016 to February 2018. Interventions: Patients were randomly assigned to a restrictive IV fluid resuscitation strategy (≤ 60ml/kg of IV fluid) or usual care for the first 72 hours of care. Measurements and Main Results: We enrolled 109 patients, of whom 55 were assigned to the restrictive resuscitation group and 54 to the usual care group. The restrictive group received

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