Intubated-ventilated Patients in the Intensive Care UnitWATERNCT03951519
Effect of Oral Water on the Quality of Volume Expansion in Resuscitation Patients
A study testing oral administration of water and administration of saline solution in people with Intubated-ventilated Patients in the Intensive Care Unit, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
In ICU and operating theatre, fluid expansion is the main hemodynamic therapeutic. The objective of fluid expansion is to increase cardiac output thus arterial oxygen delivery to match patient's oxygen consumption. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubated-ventilated Patients in the Intensive Care Unit
- What is being tested?
- oral administration of water and administration of saline solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 24 May 2019to 30 Jan 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Close family member has given written consent for patient included in emergency
- Intubated-ventilated patient in controlled volume mode
- Normothermal patient (36.5-37.5°C)
- Adult patient in intensive care for whom the attending physician has decided to give fluid expansion because of acute circulatory failure (systolic blood pressure < 90 mmHg, and/or mean blood pressure < 65 mmHg, and/or the need for infusion of vasopressor amines, and/or skin mottles, and/or diuresis < 0.5 mL/kg/h for a duration of ≥ 2 hours, and/or arterial lactate level > 2 mmol/L) (21),
- Patient with a variation OF SV over 10% with PLR,
- Echogenic patient,
- Patient with a regular sinus rhythm,
- Patient with a nasogastric tube.
Who cannot join
- Person subject to a legal protection measure (curatorship, guardianship)
- Person subject to a measure to safeguard justice
- Condition contraindicating the use of the oral route,
- Patient not affiliated or not covered by the national health system,
- Pregnant, parturient or breastfeeding woman,
- Hemodynamically unstable patient (variation of more than 10% in blood pressure),
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- Arrhythmia-like rhythm disorder by atrial fibrillation,
- Modification of therapies (sedation, catecholamines) during the study period,
- Modification of the ventilatory parameters.
- Heart failure
- Oedemato-ascitic insufficiency of cirrhosis
- Changes in drug doses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Oral Water on the Quality of Volume Expansion in Resuscitation Patients: Pilot Study (The Water Study)
In ICU and operating theatre, fluid expansion is the main hemodynamic therapeutic. The objective of fluid expansion is to increase cardiac output thus arterial oxygen delivery to match patient's oxygen consumption. To date, it has been shown that all fluid expansion solutions may have side effects (hydro-electrolytic disorder, renal failure, hydro-sodium overload, etc.) that may limit their use.
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), that of oral water vary in the literature depending on the physiological state of the patient and the clinical state. Oral water can change cardiac output and blood pressure through various physiological effects: increased blood volume, recruitment of splanchnic blood volume, and peripheral vasoconstriction. Usually, ICU patients have feeding through nasogastric tube.
To date, no study has studied the effect of a given amount of enteral cardiovascular system in ICU patients. The objective of this study is to describe the effect of oral water administration on the cardiovascular system of patients during the optimization and/or hemodynamic stabilization phase. The comparison of groups (water/ physiological saline) would allow us: (1) to describe the cardiovascular effects of water in the resuscitation patient, (2) to compare these cardiovascular effects with those of saline solution, (3) to have the data to design further study.
- Being tested
- oral administration of water, administration of saline solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral administration of waterOther
Volume expansion via 500 mL of water administered by the patient's nasogastric tube
administration of saline solutionOther
Volume expansion via 500 mL of saline (Nacl 0.9%) administered by the venous route
| Study group | Role | What they receive |
|---|---|---|
| Water | Experimental | Not described Receives: Other: oral administration of water |
| Physiological serum | Active comparator | Not described Receives: Other: administration of saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic ejection volume
variation in systolic ejection volume between base (time 1) and end of filling (time 2), expressed as a percentage.
Measured: 60 minutes
Secondary outcomes (9)
Blood pressure
Measured: immediately, 30 and 60 minutes after fluid administration
Cardiac output
Measured: immediately, 30 and 60 minutes after fluid administration,
volume of systolic ejections
Measured: immediately, 30 and 60 minutes after fluid administration
arterial lactate level
Measured: immediately after filling, 60 minutes after fluid administration,
Hourly diuresis
Measured: 60 minutes after fluid administration
change in DO2
Measured: after filling, 60 minutes after fluid administration
change in VO2
Measured: after filling, 60 minutes after fluid administration
number ofAdverse effects of water administration
(nausea, vomiting),
Measured: "through study completion, an average of 1 year".
number Adverse effects of saline administration
(natremia, chloremia, acute pulmonary edema, renal failure).
Measured: "through study completion, an average of 1 year".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start24 May 2019
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intubated-ventilated Patients in the Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951519
- Sponsor's protocol ID
- GUINOT 2018-2
- Acronym
- WATER
- Status last verified
- Jan 2026
- First submitted
- 10 May 2019
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guinot PG, Nguyen M, Duclos V, Soudry-Faure A, Bouhemad B; Water Study Group. Oral water ingestion in the treatment of shock patients: a prospective randomized study. Intensive Care Med. 2020 Nov;46(11):2111-2112. doi: 10.1007/s00134-020-06215-y. Epub 2020 Aug 26. No abstract available.
PubMed 32851490Guinot PG, Nguyen M, Duclos V, Berthoud V, Bouhemad B; water study group. Oral Water Has Cardiovascular Effects Up to 60 min in Shock Patients. Front Cardiovasc Med. 2021 Dec 20;8:803979. doi: 10.3389/fcvm.2021.803979. eCollection 2021.
PubMed 34988132
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Water on the Quality of Volume Expansion in Resuscitation Patients: Pilot Study (The Water Study)
- ClinicalTrials.gov ID
- NCT03951519
- Acronym / sponsor ID
- WATER / GUINOT 2018-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 24 May 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 15 May 2019 (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.
In ICU and operating theatre, fluid expansion is the main hemodynamic therapeutic. The objective of fluid expansion is to increase cardiac output thus arterial oxygen delivery to match patient's oxygen consumption. To date, it has been shown that all fluid expansion solutions may have side effects (hydro-electrolytic disorder, renal failure, hydro-sodium overload, etc.) that may limit their use.
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), that of oral water vary in the literature depending on the physiological state of the patient and the clinical state. Oral water can change cardiac output and blood pressure through various physiological effects: increased blood volume, recruitment of splanchnic blood volume, and peripheral vasoconstriction. Usually, ICU patients have feeding through nasogastric tube.
To date, no study has studied the effect of a given amount of enteral cardiovascular system in ICU patients. The objective of this study is to describe the effect of oral water administration on the cardiovascular system of patients during the optimization and/or hemodynamic stabilization phase. The comparison of groups (water/ physiological saline) would allow us: (1) to describe the cardiovascular effects of water in the resuscitation patient, (2) to compare these cardiovascular effects with those of saline solution, (3) to have the data to design further study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water | Experimental | Other: oral administration of water |
| Physiological serum | Active comparator | Other: administration of saline solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Close family member has given written consent for patient included in emergency
- Intubated-ventilated patient in controlled volume mode
- Normothermal patient (36.5-37.5°C)
- Adult patient in intensive care for whom the attending physician has decided to give fluid expansion because of acute circulatory failure (systolic blood pressure < 90 mmHg, and/or mean blood pressure < 65 mmHg, and/or the need for infusion of vasopressor amines, and/or skin mottles, and/or diuresis < 0.5 mL/kg/h for a duration of ≥ 2 hours, and/or arterial lactate level > 2 mmol/L) (21),
- Patient with a variation OF SV over 10% with PLR,
Key exclusion criteria (12 listed)
- Person subject to a legal protection measure (curatorship, guardianship)
- Person subject to a measure to safeguard justice
- Condition contraindicating the use of the oral route,
- Patient not affiliated or not covered by the national health system,
- Pregnant, parturient or breastfeeding woman,
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 administration of waterVolume expansion via 500 mL of water administered by the patient's nasogastric tube | Other | Water |
| administration of saline solutionVolume expansion via 500 mL of saline (Nacl 0.9%) administered by the venous route | Other | Physiological serum |
Primary outcome
systolic ejection volume
Time frame: 60 minutes
variation in systolic ejection volume between base (time 1) and end of filling (time 2), expressed as a percentage.
9 secondary outcomes
Blood pressure
Time frame: immediately, 30 and 60 minutes after fluid administration
Cardiac output
Time frame: immediately, 30 and 60 minutes after fluid administration,
volume of systolic ejections
Time frame: immediately, 30 and 60 minutes after fluid administration
arterial lactate level
Time frame: immediately after filling, 60 minutes after fluid administration,
Hourly diuresis
Time frame: 60 minutes after fluid administration
change in DO2
Time frame: after filling, 60 minutes after fluid administration
change in VO2
Time frame: after filling, 60 minutes after fluid administration
number ofAdverse effects of water administration
Time frame: "through study completion, an average of 1 year".
number Adverse effects of saline administration
Time frame: "through study completion, an average of 1 year".
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 3 Feb 2026.
- Results publication: PubMed 32851490Guinot PG, Nguyen M, Duclos V, Soudry-Faure A, Bouhemad B; Water Study Group. Oral water ingestion in the treatment of shock patients: a prospective randomized study. Intensive Care Med. 2020 Nov;46(11):2111-2112. doi: 10.1007/s00134-020-06215-y. Epub 2020 Aug 26. No abstract available.
- Derived from this study: PubMed 34988132Guinot PG, Nguyen M, Duclos V, Berthoud V, Bouhemad B; water study group. Oral Water Has Cardiovascular Effects Up to 60 min in Shock Patients. Front Cardiovasc Med. 2021 Dec 20;8:803979. doi: 10.3389/fcvm.2021.803979. eCollection 2021.
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 oral administration of water and administration of saline solution in people with Intubated-ventilated Patients in the Intensive Care Unit, run by Centre Hospitalier Universitaire Dijon 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 8 inclusion and 12 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 3 Feb 2026. 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?
systolic ejection volume (time frame: 60 minutes). 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 NCT03951519, which also lists 2 linked publications.
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 3 Feb 2026.