Oral Versus Intravenous Fluid Therapy in the Emergency Department

Overview

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

Interventions

• Other Oral fluids
  Any fluid volume prescribed by the physician during the ED stay is administered orally.
• Other Intravenous fluids
  Any fluid volume prescribed by the physician during the ED stay is administered intravenously.

Primary outcome measures

• Percentage of patients achieving the fluid volume prescribed during the first 48 hours in the emergency department [Time frame: From inclusion until end of participation. End of participation is defined as the timepoint of leaving the emergency department or after 48 hours, whichever happens first.]

Secondary outcome measures (6)

• Fluids received in the ED (ml) [Time frame: From inclusion to end of participation (defined as ED stay or maximum of 48 hours), unless mentioned otherwise]
• Fluids received in the ED after inclusion in the study (ml) [Time frame: From inclusion to end of participation (defined as ED stay or maximum of 48 hours), unless mentioned otherwise]
• Change in systolic and mean arterial pressure at 8 hours or discharge, whatever comes first. [Time frame: 8 hours or discharge, whatever comes first.]
• Hospital-free days alive at 30 days (counting up to the day the patient deceased if applicable) [Time frame: 30 days]
• Mortality at 30 days [Time frame: 30 days]
• Number of hours with a peripheral intravenous catheter [Time frame: From inclusion to end of participation (defined as ED stay or maximum of 48 hours), unless mentioned otherwise]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Denmark · 3 centers

• Emergency Department, South Jutland Hospital — Aabenraa
• Emergency Department, Esbjerg Hospital — Esbjerg
• Odense University Hospital — Odense

Identifiers

NCT: NCT07361952 · S-20250042

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗