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NCT Number: NCT07052461

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, 4031, Switzerland

Location status: Recruiting

Location contact

Alexa Hollinger, MD

SUB_INVESTIGATOR

Gregor Loosen, MD

CONTACT

[email protected]

+41 61 328 40 90

Gregor Loosen, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 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).

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

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

  4. 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

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

Secondary outcomes

  1. 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 in RBCv between patients with a Vexus score of 0 vs. 1 vs. 2 vs. 3

  2. 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 inTVD between patients with a Vexus score of 0 vs. 1 vs. 2 vs. 3

  3. 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 between patients grouped as congested (Vexus score of 2 and 3) vs. non-congested (Vexus score of 0 and 1)

  4. 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

    Difference in microcirculatory reserve capacity between patients with a physiologic femoral vein flow vs. pulsatile patern

Study contacts

Contact information is provided by the study sponsor or research team.

Gregor Loosen,, MD

CONTACT

[email protected]

+41 61 328 40 90

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: VeMic

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 4, 2025
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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