- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Dijon, Frankrig, 21000
- Chu Dijon Bourogne
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
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
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- GUINOT 2018-2
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med oral administration of water
-
Glock Health, Science and Research GmbHUkendtIrritabel tyktarm med diarré (IBS-D)Østrig
-
Medicines for Malaria VentureRichmond Pharmacology LimitedAfsluttetMalariaDet Forenede Kongerige
-
Taiho Oncology, Inc.RekrutteringIkke-småcellet lungekræftForenede Stater, Frankrig, Italien, Korea, Republikken, Japan, Spanien, Tyskland, Holland, Det Forenede Kongerige
-
Sakarya UniversityUkendtOral råmælksadministration hos for tidligt fødte spædbørn med meget lav fødselsvægtKalkun
-
Yonsei UniversityAfsluttetType 2 diabetes | Ikke-alkoholisk fedtleversygdomKorea, Republikken
-
Milton S. Hershey Medical CenterAfsluttetProcedurel smerteForenede Stater
-
Basilea PharmaceuticaAfsluttetNeoplasmerBelgien, Det Forenede Kongerige, Tyskland, Schweiz
-
PfizerMedivation, Inc.Afsluttet
-
Vertex Pharmaceuticals IncorporatedAfsluttetMyelomatose | Hodgkins lymfom | Non-Hodgkins lymfom | Waldenstroms makroglobulinæmi | Akut leukæmi | Kronisk leukæmiForenede Stater
-
Jianning YaoIkke rekrutterer endnu