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

Esbjerg Hospital - University Hospital of Southern Denmark

Status: Enrolling

Conditions: Fluid Management

Treatments: Other: Intravenous fluids; Other: Oral fluids

Study type: Interventional

Funder types: Other

Identifiers

NCT07361952

S-20250042

Details and patient eligibility

About

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

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Intravenous fluids

Active Comparator group

Description:

Participants randomized to receive IV crystalloid fluids during ED stay

Treatment:

Other: Intravenous fluids

Oral fluids

Experimental group

Description:

Participants randomized to receive oral tap water during ED stay

Treatment:

Other: Oral fluids