NCT07052461

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
17mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Sep 2027

First Submitted

Initial submission to the registry

June 26, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 4, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

April 14, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

June 26, 2025

Last Update Submit

April 15, 2026

Conditions

Keywords

vexus scorefemoral vein dopplerintensive care unit

Outcome Measures

Primary Outcomes (4)

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

    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).

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

  • Difference in total vessel density: concested vs non-congested

    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 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

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

    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

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

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

Secondary Outcomes (4)

  • 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

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients presenting for elective or urgent cardiac surgery. Urgent patients are defined as patients who have not been electively admitted for operation but who require intervention or surgery on the current admission for medical reasons. These patients cannot be sent home without a definitive procedure but do not require immediate emergency surgery.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Hyperemia

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Martin Siegemund, Prof. MD

    University Hospital of Basel

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2025

First Posted

July 4, 2025

Study Start

April 14, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2027

Last Updated

April 20, 2026

Record last verified: 2026-04

Locations