Fluid Management
Conditions
Keywords
oral fluids, Emergency department, intravenous fluids, fluid management
Brief summary
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
OTHEROral fluids
Any fluid volume prescribed by the physician during the ED stay is administered orally.
OTHERIntravenous fluids
Any fluid volume prescribed by the physician during the ED stay is administered intravenously.
Sponsors
Esbjerg Hospital - University Hospital of Southern Denmark
Odense University Hospital
Hospital of Southern Jutland, Aabenraa, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving the fluid volume prescribed during the first 48 hours in the emergency department | 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
| Measure | Time frame | Description |
|---|---|---|
| Fluids received in the ED (ml) | From inclusion to end of participation (defined as ED stay or maximum of 48 hours), unless mentioned otherwise | Intravenous fluids, oral fluids, total fluids |
| Fluids received in the ED after inclusion in the study (ml) | From inclusion to end of participation (defined as ED stay or maximum of 48 hours), unless mentioned otherwise | Intravenous fluids, oral fluids, total fluids |
| Change in systolic and mean arterial pressure at 8 hours or discharge, whatever comes first. | 8 hours or discharge, whatever comes first. | — |
| Hospital-free days alive at 30 days (counting up to the day the patient deceased if applicable) | 30 days | — |
| Mortality at 30 days | 30 days | — |
| Number of hours with a peripheral intravenous catheter | From inclusion to end of participation (defined as ED stay or maximum of 48 hours), unless mentioned otherwise | — |
Countries
Denmark
Outcome results
None listed