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| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
| Hospital of Southern Jutland, Aabenraa, Denmark | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous fluids | Active Comparator | Participants randomized to receive IV crystalloid fluids during ED stay |
|
| Oral fluids | Experimental | Participants randomized to receive oral tap water during ED stay |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral fluids | Other | Any fluid volume prescribed by the physician during the ED stay is administered orally. |
|
| Measure | Description | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fluids received in the ED (ml) | Intravenous fluids, oral fluids, total fluids | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Department, South Jutland Hospital | Recruiting | Aabenraa | Denmark |
De-identified IPD available upon reasonable request, subject to approval and data protection regulations.
Data will be available upon reasonable request beginning after publication of the primary results and ending 5 years thereafter.
Access to de-identified individual participant data (IPD) and supporting documentation will be granted to qualified researchers upon reasonable request. Requests must include a written proposal describing the research question, planned analyses, and intended use of the data. Proposed analyses must be scientifically sound and consistent with the scope of the original study.
Requests will be reviewed by the study investigators to assess scientific merit, feasibility, and compliance with ethical approvals and data protection regulations. Where required, approval from relevant ethics committees or data protection authorities must be obtained prior to data access.
Data sharing will be subject to the execution of a data sharing agreement outlining the terms of use, data security requirements, and restrictions on onward sharing. Data will be provided in a secure format and access will be limited to the approved analyses.
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| ID | Term |
|---|---|
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005440 | Fluid Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Intravenous fluids | Other | Any fluid volume prescribed by the physician during the ED stay is administered intravenously. |
|
Intravenous fluids, oral fluids, total fluids
| 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. | 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 |
| Emergency Department, Esbjerg Hospital | Recruiting | Esbjerg | 6700 | Denmark |
|
| Odense University Hospital | Recruiting | Odense | 5000 | Denmark |
|