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Идёт набор NCT07052461

Association of Microcirculation, Vexus Score and Femoral Vein Doppler in Patients on the ICU After Non-emergency Cardiac Surgery

Наблюдательное Microcirculatory Diffusion Microcirculatory Convection Capacity Venous Congestion Postoperative Cardiac Surgery

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Microcirculatory Diffusion, Microcirculatory Convection Capacity, Venous Congestion, Postoperative Cardiac Surgery. 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
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The aim of the VeMic study is to explore if venous congestion is linked with microcirculatory impairment in elective cardiac surgery patients in the postoperative ICU stay.

Подробное описание

Cardiac surgery is associated with a significant risk of postoperative complications, including organ dysfunction such as acute kidney injury (AKI). Traditionally, clinical management in the intensive care unit (ICU) has focused on monitoring macrocirculatory parameters-such as blood pressure, cardiac output, and central venous pressure (CVP)-to guide treatment. However, adequate systemic perfusion does not always translate into sufficient tissue oxygenation at the microcirculatory level. Microcirculation, which occurs in the smallest vessels such as capillaries, is where oxygen and nutrients are actually delivered to the cells. Impairment in microcirculatory function can occur even when macrocirculatory values appear normal, leading to what is known as loss of hemodynamic coherence. Despite growing evidence of the clinical importance of microcirculation, routine bedside assessment remains limited due to technical challenges and the lack of easily applicable tools.

While elevated CVP and signs of venous congestion have been linked to worse outcomes such as AKI, the underlying mechanisms remain poorly understood. CVP alone is an imperfect marker for venous stasis and does not reliably predict microcirculatory impairment. Newer ultrasound-based tools-such as the Vexus score and femoral vein Doppler (FVD)-are emerging as promising, non-invasive methods to assess venous congestion at the bedside. However, it is currently unclear whether these sonographic signs of venous congestion are actually associated with impaired microcirculatory function. This knowledge gap limits clinicians' ability to interpret ultrasound findings in the context of microvascular health and to make informed decisions about fluid management and organ perfusion.

The VeMic study aims to investigate whether ultrasound-based indicators of venous congestion correlate with objectively measured microcirculatory impairment in patients admitted to the ICU after non-emergency cardiac surgery. By combining ultrasound assessments with advanced analysis of sublingual microcirculation using handheld vital microscopy and automated software, the study seeks to bridge the gap between macro- and microcirculatory monitoring. The findings may help determine whether these easily accessible ultrasound tools can be used to detect early signs of microvascular dysfunction and guide more targeted, physiology-based interventions in the postoperative setting.

Первичные конечные точки

  • Difference in red blood cell velocity: concested vs non-congested [Срок оценки: 3 measurements:T0 prior surgery, T1 first post-operative day, T2 6 hours after T1]
  • Difference in total vessel density: concested vs non-congested [Срок оценки: 3 measurements:T0 prior surgery, T1 first post-operative day, T2 6 hours after T1]
  • Difference in red blood cell velocity: physiologic femoral vein flow vs. pulsatile pattern [Срок оценки: 3 measurements:T0 prior surgery, T1 first post-operative day, T2 6 hours after T1]
  • Difference in total vessel density between patients with a physiologic femoral vein flow vs. pulsatile pattern [Срок оценки: 3 measurements:T0 prior surgery, T1 first post-operative day, T2 6 hours after T1]
Вторичные конечные точки (4)
  • Difference in RBCv between patients with different Vexus scores [Срок оценки: 3 measurements:T0 prior surgery, T1 first post-operative day, T2 6 hours after T1]
  • Difference inTVD between patients with different Vexus scores [Срок оценки: 3 measurements:T0 prior surgery, T1 first post-operative day, T2 6 hours after T1]
  • Difference in microcirculatory reserve capacity: congested non-congested [Срок оценки: 3 measurements:T0 prior surgery, T1 first post-operative day, T2 6 hours after T1]
  • Difference in microcirculatory reserve capacity: physiologic femoral vein flow vs. pulsatile patern [Срок оценки: 3 measurements:T0 prior surgery, T1 first post-operative day, T2 6 hours after T1]

Критерии участия

Критерии включения

  • Age ≥ 18 years
  • Elective or urgent (need for definitive procedure during hospitalisation, but not emergency intervention) cardiac surgery

Критерии исключения

  • Age < 18 years
  • Pregnant women
  • Known severe chronic kidney disease (estimated glomerular filtration rate <15 mL/min per 1.73 m2 or dialysis)
  • Renal or liver transplantation
  • Any known condition interfering with Doppler evaluation of the portal system (including known or suspected cirrhosis or portal vein thrombosis or huge abdominal emphysema).
  • Inability to consent to study
  • Emergency cardiac surgery

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швейцария · 1 центр
  • University Hospital Basel — Basel

Идентификаторы

NCT: NCT07052461 · 2025-00579; am24Siegemund

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗