Effect of Oral Water in Healthy Volunteers on Cardiac Output, Regional Flow and Microcirculation in Healthy Volunteers (WATERNAL)

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 Overview

• Status: Completed
• Conditions: Fluid Therapy; Pharmacodynamics; Fluid Responsiveness; Fluid Challenge; Intravenous Fluids
• Intervention / Treatment: Other: oral water; Other: saline intravenous administration

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU AMIENS-PICARDIE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: oral water; Experimental group: oral administration of 500 ml of water.	Other: oral water; 500 ml oral water
Active Comparator: intravenous; Active comparator: Administration of 500 mL of saline (NaCl 0.9%) administered by the venous route	Other: saline intravenous administration; Administration of 500 mL of saline (NaCl 0.9%) administered by the venous route

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of fluid responders 30 minutes after fluid expansion	30 minutes after fluid expansion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Actual): August 28, 2023
• Study Completion (Actual): August 28, 2023

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: November 30, 2021
• First Posted (Actual): December 10, 2021

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: fluid responsiveness; pharmacodynamics; intravenous fluids; fluid therapy; fluid challenge
• Other Study ID Numbers: PI2019_843_0064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No