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

NCT ID: NCT05153837

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2023-08-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

oral water

Experimental group: oral administration of 500 ml of water.

Group Type: EXPERIMENTAL

oral water

Intervention Type: OTHER

500 ml oral water

intravenous

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

Group Type: ACTIVE_COMPARATOR

saline intravenous administration

Intervention Type: OTHER

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

Interventions

saline intravenous administration

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

Intervention Type: OTHER

oral water

500 ml oral water

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens-Picardie

Amiens, , France

Countries

France

Other Identifiers

PI2019_843_0064

Identifier Type: -

Identifier Source: org_study_id