Oral vs Intravenous Fluid Therapy in Emergency Department Patients: Protocol for a Randomized Controlled Feasibility and Noninferiority Trial
Abstract
BACKGROUND
Intravenous fluid therapy is widely used in emergency departments (EDs) to treat hypovolemia and hypotension. However, its hemodynamic effects are often modest and short-lived. Intravenous fluid therapy requires a peripheral venous catheter, which increases the risk of complications such as catheter failure and phlebitis. Oral fluid therapy represents a simple, noninvasive alternative that has been shown in physiological studies to expand plasma volume and increase blood pressure. No randomized trial has compared oral with intravenous fluid therapy in a general adult ED population. Evidence regarding the feasibility of randomized comparisons of fluid administration modes and whether oral fluid administration can reliably deliver the prescribed volume remains limited.
OBJECTIVE
This study aims to evaluate the feasibility of conducting a randomized controlled trial of oral vs intravenous fluid therapy in ED patients requiring fluid replacement and to determine whether oral fluid therapy is noninferior to intravenous fluid therapy in achieving the prescribed fluid volume.
METHODS
This investigator-initiated, multicenter, open-label randomized controlled feasibility and noninferiority trial will enroll 250 adult ED patients prescribed ≥1000 mL of intravenous crystalloid therapy. Participants will be randomized 1:1 to receive either oral fluids or intravenous crystalloid. The primary feasibility outcome is protocol adherence, defined as the proportion of randomized…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 250 participants or records.
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