An interventional study of oral administration of water and administration of saline solution in Intubated-ventilated Patients in the Intensive Care Unit, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-03.
Sponsored by Centre Hospitalier Universitaire Dijon · Not applicable, Interventional, and Supportive care
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.
Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: oral administration of water
Other: administration of saline solution
Volume expansion via 500 mL of water administered by the patient's nasogastric tube
Volume expansion via 500 mL of saline (Nacl 0.9%) administered by the venous route
systolic ejection volume
variation in systolic ejection volume between base (time 1) and end of filling (time 2), expressed as a percentage.
Time frame: 60 minutes
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
(nausea, vomiting),
Time frame: "through study completion, an average of 1 year".
number Adverse effects of saline administration
(natremia, chloremia, acute pulmonary edema, renal failure).
Time frame: "through study completion, an average of 1 year".
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire Dijon