Effect of Oral Water on the Quality of Volume Expansion in Resuscitation Patients (WATER)

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.

Study Overview

• Status: Completed
• Conditions: Intubated-ventilated Patients in the Intensive Care Unit
• Intervention / Treatment: Other: oral administration of water; Other: administration of saline solution

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Chu Dijon Bourogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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),
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Water	Other: oral administration of water; Volume expansion via 500 mL of water administered by the patient's nasogastric tube
Active Comparator: Physiological serum	Other: administration of saline solution; Volume expansion via 500 mL of saline (Nacl 0.9%) administered by the venous route

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
systolic ejection volume	variation in systolic ejection volume between base (time 1) and end of filling (time 2), expressed as a percentage.	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure		immediately, 30 and 60 minutes after fluid administration
Cardiac output		immediately, 30 and 60 minutes after fluid administration,
volume of systolic ejections		immediately, 30 and 60 minutes after fluid administration
arterial lactate level		immediately after filling, 60 minutes after fluid administration,
Hourly diuresis		60 minutes after fluid administration
change in DO2		after filling, 60 minutes after fluid administration
change in VO2		after filling, 60 minutes after fluid administration
number ofAdverse effects of water administration	(nausea, vomiting),	"through study completion, an average of 1 year".
number Adverse effects of saline administration	(natremia, chloremia, acute pulmonary edema, renal failure).	"through study completion, an average of 1 year".

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Publications and helpful links

General Publications

• Guinot 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2019
• Primary Completion (Actual): January 30, 2020
• Study Completion (Actual): January 30, 2020

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: GUINOT 2018-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No