Oral versus IV fluids in the emergency department
Oral Versus Intravenous Fluid Therapy in the Emergency Department
This project will test whether drinking plain water works as well as receiving IV crystalloid fluids for adults in the emergency department who need about 1,000 mL of fluid.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Esbjerg Hospital - University Hospital of Southern Denmark Academic / other |
| Locations | 3 sites (Aabenraa and 2 other locations) |
| Trial ID | NCT07361952 on ClinicalTrials.gov |
What this trial studies
This randomized clinical feasibility trial enrolls adults in the emergency department who have at least 1,000 mL of crystalloid prescribed and randomizes them to receive either oral tap water or standard intravenous crystalloid during their ED stay. The primary clinical comparison is whether patients in the oral arm are non-inferior to the IV arm in achieving the prescribed fluid volume. The study also measures feasibility outcomes including recruitment rate and adherence to the assigned protocol. The trial is conducted at multiple hospitals in Southern Denmark and uses pragmatic procedures appropriate for the ED setting.
Who should consider this trial
Good fit: Adults aged 18 or older in the emergency department with a physician-prescribed need for at least 1,000 mL of crystalloid who are alert and able to take oral fluids and are not pregnant or severely hyponatremic are the ideal candidates.
Not a fit: Patients with an altered mental state preventing safe oral intake, pregnancy, contraindications to oral fluids (for example bowel obstruction), severe hyponatremia (<120 mEq/L), or those requiring ICU care are unlikely to benefit from the oral approach.
Why it matters
Potential benefit: If successful, using oral fluids could reduce IV catheter use, lower procedure-related complications, improve patient comfort, and decrease costs in eligible ED patients.
How similar studies have performed: Smaller and non-randomized studies have shown oral rehydration can work in some settings, but randomized evidence specifically comparing oral versus IV fluid therapy in the emergency department is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aabenraa and 2 other locations
- Emergency Department, South Jutland Hospital — Aabenraa, Denmark (Recruiting)
- Emergency Department, Esbjerg Hospital — Esbjerg, Denmark (Recruiting)
- Odense University Hospital — Odense, Denmark (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.