Fluid ManagementOVID-BNCT07361952
Oral Versus Intravenous Fluid Therapy in the Emergency Department
A study testing Oral fluids and Intravenous fluids in people with Fluid Management, run by Esbjerg Hospital - University Hospital of Southern Denmark at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Management
- What is being tested?
- Oral fluids and Intravenous fluids
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesDenmark
- Study dates
- 3 Oct 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or above
- At least 1000 ml of crystalloid fluid therapy prescribed by the physician
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 3 recruiting
- Recruiting
Emergency Department, South Jutland Hospital
Aabenraa
Christian Backer Mogensen, MD, PHD, +45 79971123, CBM1@rsyd.dk
- Recruiting
Emergency Department, Esbjerg Hospital
Esbjerg, 6700
Peter Biesenbach, MD, +45 53861985, peter.biesenbach@rsyd.dk
- Recruiting
Odense University Hospital
Odense, 5000
Mikkel Brabrand, MD, Ph.D., +4540736373, mikkel.brabrand@rsyd.dk
About this study
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:
Read more
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
- Conditions
- Fluid Management
- Being tested
- Oral fluids, Intravenous fluids
- Keywords
- oral fluids, Emergency department, intravenous fluids, fluid management
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral fluidsOther
Any fluid volume prescribed by the physician during the ED stay is administered orally.
Intravenous fluidsOther
Any fluid volume prescribed by the physician during the ED stay is administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous fluids | Active comparator | Participants randomized to receive IV crystalloid fluids during ED stay Receives: Other: Intravenous fluids |
| Oral fluids | Experimental | Participants randomized to receive oral tap water during ED stay Receives: Other: Oral fluids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients achieving the fluid volume prescribed during the first 48 hours in the emergency department
Measured: 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 outcomes (6)
Fluids received in the ED (ml)
Intravenous fluids, oral fluids, total fluids
Measured: 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)
Intravenous fluids, oral fluids, total fluids
Measured: 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.
Measured: 8 hours or discharge, whatever comes first.
Hospital-free days alive at 30 days (counting up to the day the patient deceased if applicable)
Measured: 30 days
Mortality at 30 days
Measured: 30 days
Number of hours with a peripheral intravenous catheter
Measured: From inclusion to end of participation (defined as ED stay or maximum of 48 hours), unless mentioned otherwise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start3 Oct 2025
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fluid ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Hospital of Southern Jutland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361952
- Sponsor's protocol ID
- S-20250042
- Acronym
- OVID-B
- Status last verified
- Jan 2026
- First submitted
- 29 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD available upon reasonable request, subject to approval and data protection regulations.
Publications
Biesenbach P, Kristensen MR, Brabrand M, Mogensen CB, Laugesen LE. Oral vs Intravenous Fluid Therapy in Emergency Department Patients: Protocol for a Randomized Controlled Feasibility and Noninferiority Trial. JMIR Res Protoc. 2026 Sep 30;15:e95459. doi: 10.2196/95459.
PubMed 42814483
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Versus Intravenous Fluid Therapy in the Emergency Department
- ClinicalTrials.gov ID
- NCT07361952
- Acronym / sponsor ID
- OVID-B / S-20250042
- Conditions
- Fluid Management
- Keywords
- oral fluids, Emergency department, intravenous fluids, fluid management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital, Hospital of Southern Jutland
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous fluids | Active comparator | Other: Intravenous fluidsParticipants randomized to receive IV crystalloid fluids during ED stay |
| Oral fluids | Experimental | Other: Oral fluidsParticipants randomized to receive oral tap water during ED stay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 or above
- At least 1000 ml of crystalloid fluid therapy prescribed by the physician
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral fluidsAny fluid volume prescribed by the physician during the ED stay is administered orally. | Other | Oral fluids |
| Intravenous fluidsAny fluid volume prescribed by the physician during the ED stay is administered intravenously. | Other | Intravenous fluids |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Derived from this study: PubMed 42814483Biesenbach P, Kristensen MR, Brabrand M, Mogensen CB, Laugesen LE. Oral vs Intravenous Fluid Therapy in Emergency Department Patients: Protocol for a Randomized Controlled Feasibility and Noninferiority Trial. JMIR Res Protoc. 2026 Sep 30;15:e95459. doi: 10.2196/95459.
- Individual participant dataSharing planned: Yes. De-identified IPD available upon reasonable request, subject to approval and data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral fluids and Intravenous fluids in people with Fluid Management, run by Esbjerg Hospital - University Hospital of Southern Denmark at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07361952, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.