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NCT03951519: WATER

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

Completed NA Last updated 3 February 2026
What this trial tests

NA trial testing oral administration of water in Intubated-ventilated Patients in the Intensive Care Unit in 50 participants. Completed in 30 January 2020.

Timeline
24 May 2019
Primary endpoint
30 January 2020
30 January 2020

Quick facts

Lead sponsorCentre Hospitalier Universitaire Dijon
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment50
Start date24 May 2019
Primary completion30 January 2020
Estimated completion30 January 2020
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Centre Hospitalier Universitaire Dijon

Who can join

18 and older, any sex, with Intubated-ventilated Patients in the Intensive Care Unit. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. ESICM LIVES 2020.
    · 2020 · cited 13× · PMID 33313986 · DOI 10.1186/s40635-020-00354-8
  2. Oral Water Has Cardiovascular Effects Up to 60 min in Shock Patients.
    Guinot PG, Nguyen M, Duclos V, Berthoud V, et al · · 2021 · cited 1× · PMID 34988132 · DOI 10.3389/fcvm.2021.803979

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03951519.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing