Oral Versus Intravenous Fluid Therapy in the Emergency Department

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEsbjerg Hospital - University Hospital of Southern Denmark

About this trial

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

Eligibility criteria

Qualifiers

Age 18 or above

At least 1000 ml of crystalloid fluid therapy prescribed by the physician

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Oral fluids
  • Intravenous fluids

Treatment groups

250 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Esbjerg Hospital - University Hospital of Southern Denmark

Lead sponsor

Odense University Hospital

Collaborator

Hospital of Southern Jutland, Aabenraa, Denmark

Collaborator