跳至主要内容
临床试验/NCT07052461
NCT07052461招募中不适用

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

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年4月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Difference in red blood cell velocity: concested vs non-congested

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

结局指标

主要结局

Difference in red blood cell velocity: concested vs non-congested

时间窗: 3 measurements:T0 prior surgery, T1 first post-operative day, T2 6 hours after T1

Difference in red blood cell velocity (RBCv) between patients grouped as congested (Vexus score of 2 and 3) vs. non-congested (Vexus score of 0 and 1).

Difference in total vessel density: concested vs non-congested

时间窗: 3 measurements:T0 prior surgery, T1 first post-operative day, T2 6 hours after T1

Difference in total vessel density (TVD) between patients grouped as congested (Vexus score of 2 and 3) vs. non-congested (Vexus score of 0 and 1).

Difference in red blood cell velocity: physiologic femoral vein flow vs. pulsatile pattern

时间窗: 3 measurements:T0 prior surgery, T1 first post-operative day, T2 6 hours after T1

Difference in red blood cell velocity (RBCv) between patients with a physiologic femoral vein flow vs. pulsatile pattern

Difference in total vessel density between patients with a physiologic femoral vein flow vs. pulsatile pattern

时间窗: 3 measurements:T0 prior surgery, T1 first post-operative day, T2 6 hours after T1

Difference in total vessel density (TVD) between patients with a physiologic femoral vein flow vs. pulsatile pattern

次要结局

  • Difference in microcirculatory reserve capacity: physiologic femoral vein flow vs. pulsatile patern(3 measurements:T0 prior surgery, T1 first post-operative day, T2 6 hours after T1)
  • Difference in RBCv between patients with different Vexus scores(3 measurements:T0 prior surgery, T1 first post-operative day, T2 6 hours after T1)
  • Difference inTVD between patients with different Vexus scores(3 measurements:T0 prior surgery, T1 first post-operative day, T2 6 hours after T1)
  • Difference in microcirculatory reserve capacity: congested non-congested(3 measurements:T0 prior surgery, T1 first post-operative day, T2 6 hours after T1)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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