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
Age 18 or above
At least 1000 ml of crystalloid fluid therapy prescribed by the physician
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)
Parallel
Oral fluids
Other interventionAny fluid volume prescribed by the physician during the ED stay is administered orally.
Intravenous fluids
Other interventionAny fluid volume prescribed by the physician during the ED stay is administered intravenously.
Percentage of patients achieving the fluid volume prescribed during the first 48 hours in the emergency department
Fluids received in the ED (ml)
Intravenous fluids, oral fluids, total fluids
Fluids received in the ED after inclusion in the study (ml)
Intravenous fluids, oral fluids, total fluids
Change in systolic and mean arterial pressure at 8 hours or discharge, whatever comes first.
Hospital-free days alive at 30 days (counting up to the day the patient deceased if applicable)
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Esbjerg Hospital - University Hospital of Southern Denmark
Lead sponsor
Odense University Hospital
Collaborator
Hospital of Southern Jutland, Aabenraa, Denmark
Collaborator
