JMIR Publications

ABSTRACT

Introduction: Intravenous fluid therapy is widely used in emergency departments (ED) to treat hypovolemia but is invasive and associated with potential complications. Oral fluid therapy represents a non-invasive alternative; however, evidence regarding its feasibility and its ability to achieve prescribed fluid volumes in ED patients is limited. This trial aims to evaluate the feasibility of oral fluid therapy and to determine whether it is non-inferior to intravenous fluid therapy in achieving prescribed fluid volumes. Methods and analysis: This investigator-initiated, multicenter, open-label, randomized controlled feasibility and non-inferiority trial will enroll 250 adult ED patients requiring fluid therapy. Participants are randomized 1:1 to receive oral fluid therapy or intravenous isotonic crystalloid. The primary feasibility outcome is protocol adherence. The primary clinical outcome is the proportion of patients achieving the prescribed fluid volume, analyzed using a non-inferiority method. Secondary outcomes include fluid volume received, length-of-stay, hospital free days, peripheral cannula use, acute kidney injury, severe electrolyte imbalance, blood pressure and feasibility measures. Analyses will follow the intention-to-treat principle. Recruitment began in 2025 and is ongoing. Ethics and dissemination: The study has received approval from the Danish ethics committee and data protection authorities. Results will be disseminated through peer-reviewed journals and scientific conferences.