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

26. juni 2020 opdateret af: Centre Hospitalier Universitaire Dijon

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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Dijon, Frankrig, 21000
        • Chu Dijon Bourogne

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Vand
Volume expansion via 500 mL of water administered by the patient's nasogastric tube
Aktiv komparator: Physiological serum
Volume expansion via 500 mL of saline (Nacl 0.9%) administered by the venous route

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
systolic ejection volume
Tidsramme: 60 minutes
variation in systolic ejection volume between base (time 1) and end of filling (time 2), expressed as a percentage.
60 minutes

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood pressure
Tidsramme: immediately, 30 and 60 minutes after fluid administration
immediately, 30 and 60 minutes after fluid administration
Cardiac output
Tidsramme: immediately, 30 and 60 minutes after fluid administration,
immediately, 30 and 60 minutes after fluid administration,
volume of systolic ejections
Tidsramme: immediately, 30 and 60 minutes after fluid administration
immediately, 30 and 60 minutes after fluid administration
arterial lactate level
Tidsramme: immediately after filling, 60 minutes after fluid administration,
immediately after filling, 60 minutes after fluid administration,
Hourly diuresis
Tidsramme: 60 minutes after fluid administration
60 minutes after fluid administration
change in DO2
Tidsramme: after filling, 60 minutes after fluid administration
after filling, 60 minutes after fluid administration
change in VO2
Tidsramme: after filling, 60 minutes after fluid administration
after filling, 60 minutes after fluid administration
number ofAdverse effects of water administration
Tidsramme: "through study completion, an average of 1 year".
(nausea, vomiting),
"through study completion, an average of 1 year".
number Adverse effects of saline administration
Tidsramme: "through study completion, an average of 1 year".
(natremia, chloremia, acute pulmonary edema, renal failure).
"through study completion, an average of 1 year".

Samarbejdspartnere og efterforskere

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Publikationer og nyttige links

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Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

24. maj 2019

Primær færdiggørelse (Faktiske)

30. januar 2020

Studieafslutning (Faktiske)

30. januar 2020

Datoer for studieregistrering

Først indsendt

10. maj 2019

Først indsendt, der opfyldte QC-kriterier

14. maj 2019

Først opslået (Faktiske)

15. maj 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juni 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juni 2020

Sidst verificeret

1. maj 2019

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • GUINOT 2018-2

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med oral administration of water

3
Abonner