Intravenous FluidsWATERNALNCT05153837
Effect of Oral Water in Healthy Volunteers on Cardiac Output, Regional Flow and Microcirculation in Healthy Volunteers
A study testing saline intravenous administration and oral water in people with Intravenous Fluids and Pharmacodynamics, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Human digestive system physiologically ensures the absorption of oral water and hydration of the human body. Water is quickly absorbed by the digestive tract with a peak between 15 and 20 minutes. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Intravenous Fluids, Pharmacodynamics, Fluid Therapy
- What is being tested?
- saline intravenous administration and oral water
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2021to 28 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteer subject between 18 and 30 years old
- patient with a regular sinus rhythm
- Echogenic subject.
- Fasting of solid and liquid since 8 h
- Subject in regular sinus rhythm.
- Written consent signed.
Who cannot join
- Any known cardiac, renal or endocrine pathology.
- Arrhythmia rhythm disorder by atrial fibrillation
- Pregnant or nursing woman.
- Pathology versus indicating Nacl administration.
- Person under tutors or curators or deprived of liberty.
- Person not affiliated to a social security scheme.
Trial locations and contacts
1 site in 1 country.
About this study
Human digestive system physiologically ensures the absorption of oral water and hydration of the human body. Water is quickly absorbed by the digestive tract with a peak between 15 and 20 minutes. It has demonstrated that oral water remains the best hydration solution that have an effect on plasma volume expansion and cardiovascular system during exercise. While the cardiovascular effect of fluid expansion by saline serum is well known (venous return, preload and cardiac output), effect of oral water varies in the literature depending on the physiological state of the patient and the clinical state. Thus, the investigators aim to investigate oral water effects on fluid responsiveness, regional blood flow and microcirculatory changes.
- Conditions
- Intravenous Fluids, Pharmacodynamics, Fluid Therapy, Fluid Responsiveness, Fluid Challenge
- Being tested
- saline intravenous administration, oral water
- Keywords
- intravenous fluids, pharmacodynamics, fluid therapy, fluid responsiveness, fluid challenge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saline intravenous administrationOther
Administration of 500 mL of saline (NaCl 0.9%) administered by the venous route
oral waterOther
500 ml oral water
| Study group | Role | What they receive |
|---|---|---|
| oral water | Experimental | Experimental group: oral administration of 500 ml of water. Receives: Other: oral water |
| intravenous | Active comparator | Active comparator: Administration of 500 mL of saline (NaCl 0.9%) administered by the venous route Receives: Other: saline intravenous administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of fluid responders 30 minutes after fluid expansion
Measured: 30 minutes after fluid expansion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start30 Nov 2021
- Primary completion28 Aug 2023
- Study completion28 Aug 2023
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 Intravenous FluidsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153837
- Sponsor's protocol ID
- PI2019_843_0064
- Acronym
- WATERNAL
- Status last verified
- May 2025
- First submitted
- 30 Nov 2021
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huette P, Beyls C, Bayart G, Guinot PG, Soriot-Thomas S, Ibrahima A, Lefebvre T, Guilbart M, Daumin C, Coupez A, Meynier J, Dupont H, Bouzerar R, Abou-Arab O, Mahjoub Y. Comparison of oral water ingestion and intravenous fluid infusion on fluid responsiveness in healthy volunteers, a prospective, randomized trial. Sci Rep. 2026 Mar 17;16(1):13938. doi: 10.1038/s41598-026-43839-4.
PubMed 41844879
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Water in Healthy Volunteers on Cardiac Output, Regional Flow and Microcirculation in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05153837
- Acronym / sponsor ID
- WATERNAL / PI2019_843_0064
- Conditions
- Intravenous Fluids, Pharmacodynamics, Fluid Therapy, Fluid Responsiveness, Fluid Challenge
- Keywords
- intravenous fluids, pharmacodynamics, fluid therapy, fluid responsiveness, fluid challenge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 10 Dec 2021 (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.
Human digestive system physiologically ensures the absorption of oral water and hydration of the human body. Water is quickly absorbed by the digestive tract with a peak between 15 and 20 minutes. It has demonstrated that oral water remains the best hydration solution that have an effect on plasma volume expansion and cardiovascular system during exercise. While the cardiovascular effect of fluid expansion by saline serum is well known (venous return, preload and cardiac output), effect of oral water varies in the literature depending on the physiological state of the patient and the clinical state. Thus, the investigators aim to investigate oral water effects on fluid responsiveness, regional blood flow and microcirculatory changes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral water | Experimental | Other: oral waterExperimental group: oral administration of 500 ml of water. |
| intravenous | Active comparator | Other: saline intravenous administrationActive comparator: Administration of 500 mL of saline (NaCl 0.9%) administered by the venous route |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy volunteer subject between 18 and 30 years old
- patient with a regular sinus rhythm
- Echogenic subject.
- Fasting of solid and liquid since 8 h
- Subject in regular sinus rhythm.
Key exclusion criteria (6 listed)
- Any known cardiac, renal or endocrine pathology.
- Arrhythmia rhythm disorder by atrial fibrillation
- Pregnant or nursing woman.
- Pathology versus indicating Nacl administration.
- Person under tutors or curators or deprived of liberty.
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 |
|---|---|---|
| saline intravenous administrationAdministration of 500 mL of saline (NaCl 0.9%) administered by the venous route | Other | intravenous |
| oral water500 ml oral water | Other | oral water |
Primary outcome
number of fluid responders 30 minutes after fluid expansion
Time frame: 30 minutes after fluid expansion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Derived from this study: PubMed 41844879Huette P, Beyls C, Bayart G, Guinot PG, Soriot-Thomas S, Ibrahima A, Lefebvre T, Guilbart M, Daumin C, Coupez A, Meynier J, Dupont H, Bouzerar R, Abou-Arab O, Mahjoub Y. Comparison of oral water ingestion and intravenous fluid infusion on fluid responsiveness in healthy volunteers, a prospective, randomized trial. Sci Rep. 2026 Mar 17;16(1):13938. doi: 10.1038/s41598-026-43839-4.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing saline intravenous administration and oral water in people with Intravenous Fluids and Pharmacodynamics, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of fluid responders 30 minutes after fluid expansion (time frame: 30 minutes after fluid expansion). 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 NCT05153837, 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 28 May 2025.