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

NCT05153837 | Completed

• 1 other identifier: PI2019_843_0064
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

intravenous fluids; pharmacodynamics; fluid therapy; fluid responsiveness; fluid challenge

Outcome Measures

Primary Outcomes (1)

• number of fluid responders 30 minutes after fluid expansion

  30 minutes after fluid expansion

Study Arms (2)

oral water

EXPERIMENTAL

Experimental group: oral administration of 500 ml of water.

Other: oral water

intravenous

ACTIVE COMPARATOR

Active comparator: Administration of 500 mL of saline (NaCl 0.9%) administered by the venous route

Other: saline intravenous administration

Interventions

saline intravenous administration OTHER

Administration of 500 mL of saline (NaCl 0.9%) administered by the venous route

intravenous

oral water OTHER

500 ml oral water

oral water

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens-Picardie

Amiens, 80054, France

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 10, 2021
• Study Start: November 30, 2021
• Primary Completion: August 28, 2023
• Study Completion: August 28, 2023
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)