- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03951519
Effect of Oral Water on the Quality of Volume Expansion in Resuscitation Patients (WATER)
Effect of Oral Water on the Quality of Volume Expansion in Resuscitation Patients: Pilot Study (The Water Study)
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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Dijon, Francie, 21000
- Chu Dijon Bourogne
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Voda
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Volume expansion via 500 mL of water administered by the patient's nasogastric tube
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Aktivní komparátor: Physiological serum
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Volume expansion via 500 mL of saline (Nacl 0.9%) administered by the venous route
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
systolic ejection volume
Časové okno: 60 minutes
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variation in systolic ejection volume between base (time 1) and end of filling (time 2), expressed as a percentage.
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60 minutes
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Blood pressure
Časové okno: immediately, 30 and 60 minutes after fluid administration
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immediately, 30 and 60 minutes after fluid administration
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Cardiac output
Časové okno: immediately, 30 and 60 minutes after fluid administration,
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immediately, 30 and 60 minutes after fluid administration,
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volume of systolic ejections
Časové okno: immediately, 30 and 60 minutes after fluid administration
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immediately, 30 and 60 minutes after fluid administration
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arterial lactate level
Časové okno: immediately after filling, 60 minutes after fluid administration,
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immediately after filling, 60 minutes after fluid administration,
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Hourly diuresis
Časové okno: 60 minutes after fluid administration
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60 minutes after fluid administration
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change in DO2
Časové okno: after filling, 60 minutes after fluid administration
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after filling, 60 minutes after fluid administration
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change in VO2
Časové okno: after filling, 60 minutes after fluid administration
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after filling, 60 minutes after fluid administration
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number ofAdverse effects of water administration
Časové okno: "through study completion, an average of 1 year".
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(nausea, vomiting),
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"through study completion, an average of 1 year".
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number Adverse effects of saline administration
Časové okno: "through study completion, an average of 1 year".
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(natremia, chloremia, acute pulmonary edema, renal failure).
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"through study completion, an average of 1 year".
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Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- Guinot PG, Nguyen M, Duclos V, Berthoud V, Bouhemad B; water study group. Oral Water Has Cardiovascular Effects Up to 60 min in Shock Patients. Front Cardiovasc Med. 2021 Dec 20;8:803979. doi: 10.3389/fcvm.2021.803979. eCollection 2021.
- Guinot PG, Nguyen M, Duclos V, Soudry-Faure A, Bouhemad B; Water Study Group. Oral water ingestion in the treatment of shock patients: a prospective randomized study. Intensive Care Med. 2020 Nov;46(11):2111-2112. doi: 10.1007/s00134-020-06215-y. Epub 2020 Aug 26. No abstract available.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- GUINOT 2018-2
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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Klinické studie na oral administration of water
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