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NCT05153837 Clinical Trial

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

Fluid Responsiveness Clinical Trial

— WATERNAL  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05153837
Other study ID # PI2019_843_0064
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 30, 2021
Est. completion date December 2023

Study information
Verified date February 2023
Source Centre Hospitalier Universitaire, Amiens
Contact Pierre Huette, MD
Phone 03.22.08.78.99
Email huette.pierre@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• saline intravenous administration
Administration of 500 mL of saline (NaCl 0.9%) administered by the venous route
• oral water
500 ml oral water

Locations
Country Name City State
France CHU Amiens-Picardie Amiens

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of fluid responders 30 minutes after fluid expansion 30 minutes after fluid expansion
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