Currently accepted at: JMIR Research Protocols
Date Submitted: Mar 16, 2026
Open Peer Review Period: Mar 16, 2026 - May 11, 2026
Date Accepted: Aug 31, 2026
(closed for review but you can still tweet)
This paper has been accepted and is currently in production.
It will appear shortly on 10.2196/95459
The final accepted version (not copyedited yet) is in this tab.
Oral versus intravenous fluid therapy in emergency department patients - protocol for a randomized controlled feasibility and non-inferiority trial
ABSTRACT
Background:
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 ability to achieve prescribed fluid volumes in ED patients remains limited.
Objective:
To evaluate the feasibility of oral fluid therapy in ED patients requiring fluid replacement and to determine whether oral fluid therapy is non-inferior to intravenous fluid therapy in achieving prescribed fluid volumes.
Methods:
This investigator-initiated, multicenter, open-label randomized controlled feasibility and non-inferiority trial will enroll 250 adult ED patients prescribed ≥1000 ml intravenous crystalloid therapy. Participants are randomized 1:1 to receive either oral fluids or intravenous crystalloid. The primary feasibility outcome is protocol adherence. The primary clinical outcome is the proportion of patients achieving the prescribed fluid volume during the ED stay, analyzed using a non-inferiority framework. Secondary outcomes include total fluid volume received, blood pressure changes, hospital-free days, peripheral intravenous catheter use, acute kidney injury, severe electrolyte imbalance, and additional feasibility measures. Analyses will follow the intention-to-treat principle.
Results:
Recruitment began in October 2025 at three Danish EDs and is ongoing. As of March 2026, we have enrolled 85 patients.
Conclusions:
This trial will evaluate whether oral fluid therapy is feasible in ED patients and whether it can achieve prescribed fluid volumes comparable to intravenous therapy. The findings will inform the design of a future definitive effectiveness trial. Clinical Trial: ClinicalTrials.gov ID NCT07361952
Citation
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.