Fluid bolus in suspected Sepsis patients with Hyperlactatemia (FISH): Study protocol for an open-labeled, randomized controlled trial
Fluid bolus in sepsis: RCT
DOI:
https://doi.org/10.54205/ccc.v32.268593Keywords:
Fluid therapy, Hyperlactatemia, Hypotension, Randomized controlled trial, SepsisAbstract
Background: The adequate preload was the goal of hemodynamic optimization for sepsis resuscitation. The fluid strategy in the early phase of sepsis is unclear.
Objective: To investigate the efficacy of a fluid bolus to prevent new-onset hypotension in suspected sepsis patients with hyperlactatemia (Point-of-care serum lactate 2-4 mmol/L).
Methods: The Fluid Bolus in Suspected Sepsis Patients with Hyperlactatemia Trial (FISH) is a single-center, open-label randomized controlled trial. Participants will be patients suspected of having sepsis with hyperlactatemia (Point-of-care serum lactate 2-4 mmol/L) in the emergency department of Srinagarind Hospital, Thailand. Eligible patients will be randomized (1:1) to one of the study arms using block randomization. They will be placed in either the fluid bolus group (intervention, 30 mL/kg within 3 hours) or the standard care group (control). The primary outcome is new-onset hypotension within 24 hours after randomization. Secondary outcomes include lactate clearance, ∆SOFA at 72-hours, organ failure, and support ‘free days’ to day 28, 28-day mortality.
Hypothesis: We hypothesize that a fluid bolus will prevent new-onset hypotension in suspected sepsis patients with hyperlactatemia (point-of-care serum lactate 2-4 mmol/L).
Discussion: The optimal strategy for intravenous fluid therapy in a patient suspected of sepsis with hyperlactatemia is unknown. This is the first randomized trial examining fluid strategy in the early phase of sepsis with mild hyperlactatemia.
Ethics and dissemination: This study obtained approval from the Center for Ethics in Human Research at Khon Kaen University (Ethics Committee number: HE661012) and was registered at the Thai Clinical Trials Registry (TCTR20230502003).
Trial registration: TCTR20230502003
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