Идёт набор NCT06839404

Pharmacodynamic Analysis of the HaemOdynamic Effects of a Standard Fluid BolUS

— Наблюдательное Shock

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: fluid challenge.
Кому может быть актуально: Состояния в реестре: Shock. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Pharmacodynamic Analysis of the HaemOdynamic Effects of a Standard Fluid BolUS - the PHOEBUS Study

Обзор

When the flow of blood ejected by the heart drops significantly, that is to say when there is "shock", one of the first treatments undertaken is often volume expansion. This treatment consists of injecting a liquid intravenously, generally in the form of a bolus, that is to say a dose of solute administered all at once, of 250 to 500 mL of fluid over approximately 10 to 30 minutes. The injected fluid expands the blood volume and fills the heart pump, in order to increase the flow it ejects. However, this treatment poses two problems. First, it is only inconsistently effective. It is possible that of the 250-500 mL of fluid administered in the standard way, only a part is effective, whereas, as the effectiveness decreases during the infusion, the rest does not increase cardiac output significantly. However, the average part of the total volume that is ineffective on a large population of patients is not well known. Second, the effects of volume expansion on cardiac output decrease rapidly after the end of administration. However, the average duration of effectiveness of a 250-500 mL fluid bolus, and the factors that influence this duration of effectiveness, are not well determined. The main objective of this research is to measure, among the volume of a fluid bolus, which part does not significantly increase cardiac output. The secondary objective is to measure the average time of effectiveness after the end of the infusion and the factors that influence it.

Вмешательства

Препарат fluid challenge
Fluid bolus of 500 mL of crystalloids given at a constant rate between 10 and 15 minutes

Первичные конечные точки

To measure, during the administration of a fluid bolus in order to perform volume expansion, the volume of fluid which causes an increase in cardiac output of less than 15%. [Срок оценки: During the fluid bolus administration (<15min)]

Вторичные конечные точки (4)

The maximum amplitude of the change induced by volume expansion in cardiac output, mean arterial pressure and central venous pressure [Срок оценки: During the fluid bolus administration (<15min)]
The delay at which this maximum effect appears in terms of cardiac output, mean arterial pressure and central venous pressure [Срок оценки: During the fluid bolus administration (<15min)]
The time following the end of the infusion from which the cardiac output becomes ≤5% of the baseline value [Срок оценки: A period of 120 minutes following the fluid infusion]
The factors that influence these pharmacokinetic variables will be determined [Срок оценки: During the study period (during fluid administration and the period of 120 minutes following the infusion)]

Критерии участия

Критерии включения

Age ≥18 years old
Hospitalisation in intensive care
Haemodynamic monitoring already in place with a pulse wave contour analysis-derived estimation of cardiac output (either calibrated or uncalibrated)
Decision taken by the clinicians in charge of the patient to perform volume expansion by intravenous infusion of a 6 mL/kg crystalloid bolus