Идёт набор NCT06910891

Hemodynamic Evaluation Using Microcirculation for Early Treatment of Septic Patients

Без фазы С лечением Sepsis Emergency Care Microcirculation

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: measurement of the peripheral perfusion index and marbling assessment.
Кому может быть актуально: Состояния в реестре: Sepsis, Emergency Care, Microcirculation. 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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Обзор

Despite early treatment, the deterioration and mortality of sepsis patients remains high. A possible explanation could be persistent tissue hypoperfusion, or undetected in the early phase despite the normalization of macro-hemodynamic parameters. This interventional study evaluates the impact of measuring microcirculation parameters by nurses on patient prognosis through early initiation of vascular filling.

Подробное описание

Sepsis and its most serious form, septic shock, are a public health problem. Sepsis is defined by the presence of organ failure, including acute circulatory failure, which combines hypovolemia, vasoplegia and cardiac dysfunction. Vascular filling is therefore a pillar of the management of septic patients to correct hypovolemia and improve perfusion and tissue oxygenation. Following numerous studies, the evaluation of peripheral microcirculation is becoming a clinical "trigger" making it possible to identify patients at risk, particularly in emergency department. In a meta-analysis, it has been showed that alterations in microcirculatory perfusion predict deterioration and mortality during severe infections. Currently, no interventional study has evaluated the impact of measuring microcirculatory perfusion (peripheral perfusion index and marbling) by nurses on patient prognosis through early initiation of vascular filling.

In this study, patients will be assessed hemodynamically using peripheral perfusion index and/or presence of mottling. If peripheral perfusion index \> 3s and/or presence of marbling a first vascular filling test of 500 cc over 30 minutes will be started after a medical control.

Patient will be followed up 7 days to determine outcome.

Вмешательства

Диагностический тест measurement of the peripheral perfusion index and marbling assessment
in addition to the classic hemodynamic parameters measured in all patients, a measurement of the peripheral perfusion index (from 1 sec to 10 sec) and marbling assessment (scale from 0 to 5) will be performed

Первичные конечные точки

Number and proportion of patients presenting clinical deterioration during emergency care [Срок оценки: between time of inclusion and 24 hours after]

Вторичные конечные точки (6)

Number and proportion of patients who received bundles (i) one hour and (ii) 3 hours of admission to the Emergency Department [Срок оценки: from admission to the Emergency Department to 3 hours after]
Difference in SOFA score (≥ 2 points) between Hours 0 and Hours 24 (24h±6h) [Срок оценки: between Hours 0 and Hours 24]
Number and proportion of deaths on Day 7 [Срок оценки: from enrollement to the end of the patient participation at Day 7]
Number and proportion of patients with hydrostatic pulmonary oedema (cardiogenic or volume overload) or receiving diuretic treatment during emergency care [Срок оценки: from enrollment to the end of the subject participation at day 7]
The correlation of the peripheral perfusion index measurement (pathological : yes/no) between the nurse and the emergency physician [Срок оценки: hour 0]
Number and proportion of patients sent home, conventional hospitalization or intensive care [Срок оценки: from enrollment to the end of the subject participation at day 7]

Критерии участия

Критерии включения

Age ≥ 18 years
Admitted to the Emergency Department for suspected Sepsis for less than 6 hours according to international Sepsis-3 definitions (high probability of infection defined by a fever greater than or equal tol to 38.3°C with a suspected infectious source + Score NEWS 2 greater than or equal to 2)
Affiliated to a social security system
Having agreed to participate in this study