Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07361952

Oral Versus Intravenous Fluid Therapy in the Emergency Department

Led by Esbjerg Hospital - University Hospital of Southern Denmark · Updated on 2026-01-23

250

Participants Needed

3

Research Sites

4 weeks

Total Duration

On this page

Sponsors

E

Esbjerg Hospital - University Hospital of Southern Denmark

Lead Sponsor

O

Odense University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

This trial aims to evaluate whether oral fluid therapy can achieve prescribed fluid volumes as effectively as intravenous fluid therapy in adult patients admitted to the emergency department who need fluid treatment. It also assesses the feasibility of conducting such a randomized trial by looking at recruitment rates and how well participants follow the protocol. The study compares oral tap water with standard intravenous crystalloid therapy to see if oral fluids are not inferior in reaching the prescribed fluid amounts. Participants will be randomly assigned to receive either oral tap water or intravenous crystalloid fluids during their emergency department stay. The fluid volume and administration rate will be determined by the treating physician. The study period covers the patient's time in the emergency department, up to a maximum of 48 hours. During the study, researchers will monitor fluid intake, vital signs, and clinical outcomes following standard care practices. They will record the percentage of patients achieving the prescribed fluid volume within 48 hours and track secondary outcomes such as changes in blood pressure, hospital-free days alive at 30 days, mortality at 30 days, total fluids received, and duration with an intravenous catheter. Follow-up information will be collected through routine health records up to 30 days after inclusion.

CONDITIONS

Brief Title

Oral Versus Intravenous Fluid Therapy in the Emergency Department

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 or above
  • At least 1000 ml of crystalloid fluid therapy prescribed by the physician
Not Eligible

You will not qualify if you...

  • Altered mental state prohibiting oral fluid intake (Glasgow Coma Scale 64 12)
  • Pregnancy
  • Oral fluids contraindicated (e.g. bowel obstruction)
  • Severe hyponatremia (sodium <120 mEq/L)
  • Requiring treatment in the intensive care unit

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 48 hours or until leaving the emergency department, whichever happens first.

Participants receive either oral fluids or intravenous fluids as prescribed by the physician during their emergency department stay.

1 to 2 visits during emergency department stay

Trial Site Locations

Total: 3 locations

1

Emergency Department, South Jutland Hospital

Aabenraa, Denmark

Actively Recruiting

2

Emergency Department, Esbjerg Hospital

Esbjerg, Denmark, 6700

Actively Recruiting

3

Odense University Hospital

Odense, Denmark, 5000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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