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Набор скоро начнётся NCT07124741

Prognostic Power of the VEXUS Score in Septic Shock: Effectiveness in Mortality Prediction

Наблюдательное Septic Shock VExUS

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: Serial VEXUS Ultrasound Evaluation.
Кому может быть актуально
Состояния в реестре: Septic Shock, VExUS. 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Prognostic Power of the VEXUS Score in Septic Shock: Efficacy in Mortality Prediction

Обзор

This study aims to evaluate the prognostic power of the VEXUS Score in predicting mortality among patients with septic shock in intensive care units.

Подробное описание

After the diagnosis of septic shock, patients will be assessed for eligibility. Following informed consent, measurements will be taken within the first 4 hours of shock onset, and treatment (inotropic and vasopressor doses, fluid challenge, corticosteroids) will be recorded. A second measurement will occur between 12 and 24 hours, and a third at 72 hours. All treatment and care protocols will be managed according to routine unit protocols.

Data will be systematically collected at three time points (0-4 hours, 12-24 hours, and 72 hours). These will include hemodynamic parameters, laboratory tests (including infection markers), need for renal replacement therapy, mechanical ventilation requirement and duration, cumulative dose and duration of vasopressor use, ICU stay, and survival status.

VEXUS Score Grading

The VEXUS score will be graded as follows:

* Grade 0 (No Congestion): No signs of venous congestion are detected. The inferior vena cava (IVC) diameter is less than 2 cm. * Grade 1 (Mild Venous Congestion): The IVC diameter is 2 cm or greater. However, hepatic, portal, or renal vein flow measurements exhibit normal waveform patterns, or only one mildly abnormal waveform pattern is present. * Grade 2 (Moderate Venous Congestion): The IVC diameter is 2 cm or greater. Additionally, analysis of hepatic, portal, or renal vein waveforms reveals one severe congestion finding. * Grade 3 (Severe Venous Congestion): The IVC diameter is 2 cm or greater. Furthermore, analysis of hepatic, portal, or renal vein waveforms shows two or more severe congestion findings.

Data will be analyzed using SPSS version 23.0, with normality assessed through visual and analytical methods (Kolmogorov-Smirnov/Shapiro-Wilk tests). Continuous variables will be compared using t-tests or Mann-Whitney U tests, and categorical variables using Chi-square tests. ROC analysis will be used to assess the predictive value of VEXUS for mortality.

Вмешательства

  • Диагностический тест Serial VEXUS Ultrasound Evaluation
    Ultrasound assessments will be performed by an experienced anesthesiologist at three time points (0-4 hours, 12-24 hours, and 72 hours)to determine the degree of venous congestion using the VEXUS Score. No treatment changes will be made based on the VEXUS findings. The scores will solely be used for prognostic correlation with mortality outcomes.

Первичные конечные точки

  • 28-day intensive care unit mortality in relation to VEXUS score [Срок оценки: Up to 28 days following intensive care unit admission.]
Вторичные конечные точки (4)
  • Need for mechanical ventilation in relation to VEXUS score [Срок оценки: Within the first 72 hours of intensive care unit admission.]
  • Duration of mechanical ventilation in relation to VEXUS score. [Срок оценки: From intensive care unit patients admission until extubation, up to 28 days.]
  • Length of intensive care unit stay in relation to VEXUS score [Срок оценки: From intensive care unit admission until intensive care unit discharge, up to 28 days.]
  • Vasopressor dose and duration in relation to VEXUS score. [Срок оценки: First 72 hours after intensive care unit admission]

Критерии участия

Критерии включения

  • Age>18
  • Patients monitored for septic shock in intensive care unit
  • Signed informed consent

Критерии исключения

  • Age <18
  • Severe obesity precluding adequate ultrasonographic imaging.
  • Patients in whom venous structures cannot be clearly assessed via ultrasonography due to anatomical or technical reasons (e.g., adhesions following abdominal surgery).
  • Patients receiving dialysis due to chronic kidney disease or initiating dialysis for acute kidney failure.
  • Chronic heart failure.
  • Patients with advanced valvular insufficiency or advanced pulmonary hypertension.
  • Patients with portal hypertension or advanced-stage liver cirrhosis.
  • Presence of acute or chronic thrombosis in the inferior vena cava or other venous structures within the scoring area.
  • Refusal to participate

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07124741 · 2024-435

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗