CompletedNot Applicable

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

France50 participantsStarted 2019-05-24

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Close family member has given written consent for patient included in emergency * Intubated-ventilated patient in controlled volume mode * Normothermal patient (36.5-37.5°C) * Adult patient in intensive care for whom the attending physician has decided to give fluid expansion because of acute circulatory failure (systolic blood pressure \< 90 mmHg, and/or mean blood pressure \< 65 mmHg, and/or the need for infusion of vasopressor amines, and/or skin mottles, and/or diuresis \< 0.5 mL/kg/h for a duration of ≥ 2 hours, and/or arterial lactate level \> 2 mmol/L) (21), * Patient with a variation OF SV over 10% with PLR, * Echogenic patient, * Patient with a regular sinus rhythm, * Patient with a nasogastric tube. Exclusion Criteria: * Person subject to a legal protection measure (curatorship, guardianship) * Person subject to a measure to safeguard justice * Condition contraindicating the use of the oral route, * Patient not affiliated or not covered by the national health system, * Pregnant, parturient or breastfeeding woman, * Hemodynamically unstable patient (variation of more than 10% in blood pressure), * Arrhythmia-like rhythm disorder by atrial fibrillation, * Modification of therapies (sedation, catecholamines) during the study period, * Modification of the ventilatory parameters. * Heart failure * Oedemato-ascitic insufficiency of cirrhosis * Changes in drug doses

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

systolic ejection volume

Timeframe: 60 minutes

Trial details

NCT IDNCT03951519

SponsorCentre Hospitalier Universitaire Dijon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01-30

View on ClinicalTrials.gov More Intubated-ventilated Patients in the Intensive Care Unit trials