Restrictive Fluids Versus Standard Care in Adults with Sepsis in the Emergency Department (REFACED) - a Multicenter, Randomized Feasibility Trial

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BACKGROUND: Fluid treatment in sepsis is a challenge and clinical equipoise exists regarding intravenous volumes. We aimed to determine if a 24-hour protocol restricting intravenous (IV) fluid was feasible in adult patients with sepsis without shock presenting to the emergency department (ED).

METHODS: The REFACED Sepsis trial is an investigator-initiated, multicenter, randomized, open-label, feasibility trial, assigning sepsis patients without shock to 24 hours of restrictive IV fluid administration or standard care. In the IV fluid restriction group fluid boluses were only permitted if pre-defined criteria for hypoperfusion occurred. Standard care was at the discretion of the treating team. The primary outcome was total IV crystalloid fluid volumes at 24 hours after randomization. Secondary outcomes included total fluid volumes, feasibility measures, and patient-centered outcomes.

RESULTS: We included 123 patients (restrictive: 61 patients and standard care: 62 patients) in the primary analysis. 32% (95% confidence interval (CI) 28% to 37%) of eligible patients meeting all inclusion criteria and no exclusion criteria were included. At 24-hours, the mean IV crystalloid fluid volumes were 562 ml (standard deviation (SD): 1076) vs. 1370 ml (SD: 1438) in the restrictive vs. standard care group (mean difference -801 ml (95% CI: -1257 to -345), p = 0.001). Protocol violations occurred in 21 (34%) patients in the fluid restrictive group. There were no differences between groups in adverse events, use of mechanical ventilation or vasopressors, acute kidney failure, length of stay, or mortality.

CONCLUSIONS: A protocol restricting IV crystalloid fluids in emergency department patients with sepsis reduced 24-hour fluid volumes compared to standard care. A future trial powered towards patient-centered outcomes appears feasible.

OriginalsprogEngelsk
TidsskriftAcademic emergency medicine : official journal of the Society for Academic Emergency Medicine
ISSN1069-6563
DOI
StatusE-pub ahead of print - 2 jun. 2022

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