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Recruiting NCT07052461

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

Observational Microcirculatory Diffusion Microcirculatory Convection Capacity Venous Congestion Postoperative Cardiac Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Microcirculatory Diffusion, Microcirculatory Convection Capacity, Venous Congestion, Postoperative Cardiac Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Primary outcome measures

  • Difference in red blood cell velocity: concested vs non-congested [Time frame: 3 measurements:T0 prior surgery, T1 first post-operative day, T2 6 hours after T1]
  • Difference in total vessel density: concested vs non-congested [Time frame: 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 [Time frame: 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 [Time frame: 3 measurements:T0 prior surgery, T1 first post-operative day, T2 6 hours after T1]
Secondary outcome measures (4)
  • Difference in RBCv between patients with different Vexus scores [Time frame: 3 measurements:T0 prior surgery, T1 first post-operative day, T2 6 hours after T1]
  • Difference inTVD between patients with different Vexus scores [Time frame: 3 measurements:T0 prior surgery, T1 first post-operative day, T2 6 hours after T1]
  • Difference in microcirculatory reserve capacity: congested non-congested [Time frame: 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 [Time frame: 3 measurements:T0 prior surgery, T1 first post-operative day, T2 6 hours after T1]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Switzerland · 1 center
  • University Hospital Basel — Basel

Identifiers

NCT: NCT07052461 · 2025-00579; am24Siegemund

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗