Oral Versus Intravenous Fluid Therapy in the Emergency Department (OVID-B)

The goal of this randomized clinical feasibility trial is to determine whether oral fluid therapy can achieve prescribed fluid volumes as effectively as intravenous fluid therapy in adult patients admitted to the emergency department who require fluid treatment.

The main questions it aims to answer are:

Are patients receiving oral fluids equally likely to achieve the prescribed fluid volume compared with patients receiving intravenous fluids?

Is it feasible to conduct a randomized trial of oral versus intravenous fluid therapy in the emergency department, based on recruitment rate and protocol adherence?

Researchers will compare oral tap water administration with standard intravenous crystalloid therapy to assess whether oral fluids are non-inferior in achieving prescribed fluid volumes and to evaluate feasibility outcomes.

Participants will:

Be randomized to receive either oral tap water or intravenous crystalloid fluids during their stay in the emergency department

Receive a fluid volume and administration rate determined by the treating physician

Be monitored according to standard clinical practice during the emergency department stay

Have fluid intake, vital signs, and clinical outcomes recorded, with follow-up through routine health records up to 30 days after inclusion

Study Overview

• Status: Recruiting
• Conditions: Fluid Management
• Intervention / Treatment: Other: Intravenous fluids; Other: Oral fluids

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aabenraa, Denmark
    • Recruiting
    • Emergency Department, South Jutland Hospital
    • Contact: Christian Backer Mogensen, MD, PHD; Phone Number: +45 79971123; Email: CBM1@rsyd.dk
  • Esbjerg, Denmark, 6700
    • Recruiting
    • Emergency Department, Esbjerg Hospital
    • Contact: Peter Biesenbach, MD; Phone Number: +45 53861985; Email: peter.biesenbach@rsyd.dk
  • Odense, Denmark, 5000
    • Recruiting
    • Odense University Hospital
    • Contact: Mikkel Brabrand, MD, Ph.D.; Phone Number: +4540736373; Email: mikkel.brabrand@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 or above
• At least 1000 ml of crystalloid fluid therapy prescribed by the physician

Exclusion Criteria:

• Altered mental state prohibiting oral fluid intake (Glasgow Coma Scale ≤ 12)
• Pregnancy
• Oral fluids contraindicated (e.g. bowel obstruction)
• Severe hyponatremia (sodium <120 mEq/L)
• Requiring treatment in the intensive care unit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravenous fluids; Participants randomized to receive IV crystalloid fluids during ED stay	Other: Intravenous fluids; Any fluid volume prescribed by the physician during the ED stay is administered intravenously.
Experimental: Oral fluids; Participants randomized to receive oral tap water during ED stay	Other: Oral fluids; Any fluid volume prescribed by the physician during the ED stay is administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients achieving the fluid volume prescribed during the first 48 hours in the emergency department	From inclusion until end of participation. End of participation is defined as the timepoint of leaving the emergency department or after 48 hours, whichever happens first.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluids received in the ED (ml)	Intravenous fluids, oral fluids, total fluids	From inclusion to end of participation (defined as ED stay or maximum of 48 hours), unless mentioned otherwise
Fluids received in the ED after inclusion in the study (ml)	Intravenous fluids, oral fluids, total fluids	From inclusion to end of participation (defined as ED stay or maximum of 48 hours), unless mentioned otherwise
Change in systolic and mean arterial pressure at 8 hours or discharge, whatever comes first.		8 hours or discharge, whatever comes first.
Hospital-free days alive at 30 days (counting up to the day the patient deceased if applicable)		30 days
Mortality at 30 days		30 days
Number of hours with a peripheral intravenous catheter		From inclusion to end of participation (defined as ED stay or maximum of 48 hours), unless mentioned otherwise

Collaborators and Investigators

• Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
• Collaborators: Odense University Hospital; Hospital of Southern Jutland, Aabenraa, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Emergency department; intravenous fluids; fluid management; oral fluids
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Emergencies; Therapeutics; Drug Therapy; Fluid Therapy
• Other Study ID Numbers: S-20250042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified IPD available upon reasonable request, subject to approval and data protection regulations.
• IPD Sharing Time Frame: Data will be available upon reasonable request beginning after publication of the primary results and ending 5 years thereafter.

IPD Sharing Access Criteria

Access to de-identified individual participant data (IPD) and supporting documentation will be granted to qualified researchers upon reasonable request. Requests must include a written proposal describing the research question, planned analyses, and intended use of the data. Proposed analyses must be scientifically sound and consistent with the scope of the original study.

Requests will be reviewed by the study investigators to assess scientific merit, feasibility, and compliance with ethical approvals and data protection regulations. Where required, approval from relevant ethics committees or data protection authorities must be obtained prior to data access.

Data sharing will be subject to the execution of a data sharing agreement outlining the terms of use, data security requirements, and restrictions on onward sharing. Data will be provided in a secure format and access will be limited to the approved analyses.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No