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NCT Number: NCT07361952

Oral Versus Intravenous Fluid Therapy in the Emergency Department

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency Department, South Jutland Hospital, Aabenraa, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral fluids

Other

Any fluid volume prescribed by the physician during the ED stay is administered orally.

Intravenous fluids

Other

Any fluid volume prescribed by the physician during the ED stay is administered intravenously.

Primary outcomes

  1. Percentage of patients achieving the fluid volume prescribed during the first 48 hours in the emergency department

    Time frame: 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 outcomes

  1. Fluids received in the ED (ml)

    Time frame: From inclusion to end of participation (defined as ED stay or maximum of 48 hours), unless mentioned otherwise

    Intravenous fluids, oral fluids, total fluids

  2. Fluids received in the ED after inclusion in the study (ml)

    Time frame: From inclusion to end of participation (defined as ED stay or maximum of 48 hours), unless mentioned otherwise

    Intravenous fluids, oral fluids, total fluids

  3. Change in systolic and mean arterial pressure at 8 hours or discharge, whatever comes first.

    Time frame: 8 hours or discharge, whatever comes first.

  4. Hospital-free days alive at 30 days (counting up to the day the patient deceased if applicable)

    Time frame: 30 days

  5. Mortality at 30 days

    Time frame: 30 days

  6. Number of hours with a peripheral intravenous catheter

    Time frame: From inclusion to end of participation (defined as ED stay or maximum of 48 hours), unless mentioned otherwise

Sponsors and collaborators

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Other

Collaborators

  • Hospital of Southern Jutland, Aabenraa, Denmark
  • Odense University Hospital

Registry information

Acronym: OVID-B

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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