• Peter C Hou, Michael R Filbin, Anthony Napoli, Joseph Feldman, Peter S Pang, Jeffrey Sankoff, Bruce M Lo, Howard Dickey-White, Robert H Birkhahn, and Nathan I Shapiro.
• *Department of Emergency Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts †Department of Emergency Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts ‡Department of Emergency Medicine, Brown University School of Medicine, Providence, Rhode Island §Department of Emergency Medicine, Hackensack University Medical Center, Hackensack, New Jersey ||Department of Emergency Medicine, Indiana University School of Medicine, Indianapolis, Indiana ¶Department of Emergency Medicine, Denver General Hospital, Denver, Colorado #Department of Emergency Medicine, Eastern Virginia Medical School/Sentara Norfolk General, Norfolk, Virginia **Department of Emergency Medicine, HMHP/Mercy Health, Northeast Ohio Medical University (NEOMED), Rootstown, Ohio ††Department of Emergency Medicine, New York Methodist Hospital, Brooklyn, New York ‡‡Department of Emergency Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts §§The Center for Vascular Biology Research, Division of Molecular and Vascular Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
• Shock. 2016 Aug 1; 46 (2): 132-8.

ObjectiveFluid responsiveness is proposed as a physiology-based method to titrate fluid therapy based on preload dependence. The objectives of this study were to determine if a fluid responsiveness protocol would decrease progression of organ dysfunction, and a fluid responsiveness protocol would facilitate a more aggressive resuscitation.MethodsProspective, 10-center, randomized interventional trial.Inclusion Criteriasuspected sepsis and lactate 2.0 to 4.0 mmol/L. Exclusion criteria (abbreviated): systolic blood pressure more than 90 mmHg, and contraindication to aggressive fluid resuscitation.Interventionfluid responsiveness protocol using Non-Invasive Cardiac Output Monitor (NICOM) to assess for fluid responsiveness (>10% increase in stroke volume in response to 5 mL/kg fluid bolus) with balance of a liter given in responsive patients.Controlstandard clinical care.Outcomesprimary-change in Sepsis-related Organ Failure Assessment (SOFA) score at least 1 over 72 h; secondary-fluids administered. Trial was initially powered at 600 patients, but stopped early due to a change in sponsor's funding priorities.ResultsSixty-four patients were enrolled with 32 in the treatment arm. There were no significant differences between arms in age, comorbidities, baseline vital signs, or SOFA scores (P > 0.05 for all). Comparing treatment versus Standard of Care-there was no difference in proportion of increase in SOFA score of at least 1 point (30% vs. 33%) (note bene underpowered, P = 1.0) or mean preprotocol fluids 1,050 mL (95% confidence interval [CI]: 786-1,314) vs. 1,031 mL (95% CI: 741-1,325) (P = 0.93); however, treatment patients received more fluids during the protocol (2,633 mL [95% CI: 2,264-3,001] vs. 1,002 mL [95% CI: 707-1,298]) (P < 0.001).ConclusionsIn this study of a "preshock" population, there was no change in progression of organ dysfunction with a fluid responsiveness protocol. A noninvasive fluid responsiveness protocol did facilitate delivery of an increased volume of fluid. Additional properly powered and enrolled outcomes studies are needed.

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