An interventional study of Venous ultrasound (inferior vena cava, portal vein, suprahepatic vein, and renal vein to calculate the VEXUS score ; femoral vein and popliteal vein) in Venous Congestion, sponsored by Centre Hospitalier Universitaire de Besancon. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Diagnostic
Shock is a common and serious cause of admission to intensive care. Vascular filling is one of the cornerstones of shock treatment, aimed at increasing cardiac output and restoring adequate organ perfusion through rapid intravenous administration of a solution. However, this vascular filling can be accompanied by venous congestion, which can be harmful. Fluid administration must therefore be sparing and carefully considered.
However, it is difficult to assess the correct amount of intravenous fluid to inject. Multi-site venous ultrasound (inferior vena cava, suprahepatic vein, portal vein, renal vein), recently published under a score called VExUS, could be a useful bedside tool for documenting venous congestion and avoiding excessive vascular filling. Nevertheless, this tool has been little evaluated in the general intensive care population, particularly in patients with acute respiratory distress syndrome (ARDS). Its link with other venous sites (femoral, popliteal) has also been little studied to date.
The main objective of our study is to describe the distribution of the VEXUS score among patients in a general intensive care unit.
The secondary objectives are:
I) SCIENTIFIC JUSTIFICATION FOR THE RESEARCH :
Shock is a common cause of admission to intensive care:
By causing hypoperfusion of vital organs (kidneys, liver, digestive tract, heart), it can lead to multiple organ failure and death. There are many causes of shock, the main one being severe infection, with approximately 49 million cases worldwide each year and approximately 11 million deaths attributable to shock each year.
Vascular filling is necessary to treat shock:
The first treatment for shock is vascular filling, which consists of the intravenous administration of an isotonic solution over a short period of time. In septic shock, international guidelines recommend injection of 30 mL/kg of fluids as early as possible within the first three hours. The aim of vascular filling is to increase left ventricular systolic ejection volume, and therefore cardiac output and organ perfusion.
Excessive vascular filling is harmful:
However, vascular filling carries a risk of congestion of the venous system. This congestive state has potentially harmful adverse effects, which are now well established: intracranial hypertension and delirium, difficulties in weaning from mechanical ventilation and excess mortality in acute respiratory distress syndrome, acute renal failure, acute congestive hepatitis, intra-abdominal hypertension, decreased intestinal motility or risk of digestive ischaemia and bacterial translocation. Cardiac effects are also plausible. This explains the now well-established statistical link between positive fluid balance and excess mortality.
Fluid administration must therefore be carefully considered and sparing. With this in mind, several authors have recently proposed a concept known as R.O.S.E., which divides resuscitation into four distinct phases: a Resuscitation phase, during which vascular filling is undoubtedly necessary; an Optimisation phase, followed by a Stabilisation phase, during which fluid administration must be adjusted to maintain adequate organ perfusion while avoiding fluid overload, and a final Evacuation phase, during which any excess fluid must be eliminated through the use of diuretics or dialysis. In other words, it is a matter of finding the right window between administering an antidote and poison, to paraphrase Paracelsus. The 2021 guidelines of the Surviving Sepsis Campaign have taken this on board, suggesting that 'to avoid over- and under-resuscitation, fluid administration beyond the initial resuscitation phase should be guided by careful monitoring of volume status and organ perfusion'.
Assessing the correct amount of vascular filling to administer is difficult Multiple tests, whether static (pulse pressure variation, etc.) or dynamic (passive leg raise test), invasive (continuous cardiac output measurement) or non-invasive (echocardiography), are currently available and their results can guide the decision on whether or not to continue vascular filling. However, while this assessment is essential, it is not sufficient on its own, as congestive heart failure can coexist with preload dependence, as demonstrated in a recent study.
Venous ultrasound can detect excess vascular filling Venous congestion should therefore be assessed at the same time. As before, a wide range of tools are available for this purpose, each with its own advantages and limitations. Clinicians can take into account recent medical history, weight gain, clinical detection of oedema in the lower parts of the body, invasive measurement of central venous pressure, echocardiographic measurements, blood biomarkers, and radiological imaging of the lungs. These investigations, which are sometimes tedious, invasive, and non-dynamic, have led to the development of other tools for measuring venous congestion, such as ultrasound of the main veins: the inferior vena cava, to which the suprahepatic veins (and the portal venous system via the liver) and renal veins are connected, and the femoral veins, among others. Preliminary work has already established a link between specific patterns of these venous flows and a congestive state.
The value of venous ultrasound in detecting excessive vascular filling has been little evaluated in the general intensive care population, particularly in patients with acute respiratory distress syndrome The most comprehensive study to date combined several of these patterns (inferior vena cava, suprahepatic vein, portal vein, and renal vein) into a single score, called VEXUS (Venous EXcess Ultrasound Grading System), graded from 0 to 3. A high score was significantly associated with an increased risk of acute renal failure in the cardiac surgery population analysed. Similar results were observed after acute coronary syndrome. A single small study was conducted in the general intensive care population. This study did not specifically evaluate VEXUS in patients with acute respiratory distress syndrome (ARDS), a condition frequently encountered in intensive care. ARDS has several specific characteristics that warrant analysis of venous congestion. On the one hand, pulmonary injury warrants early detection and treatment of congestive state, a recognised risk factor for respiratory deterioration and excess mortality. On the other hand, hypoxaemia and its treatment with high-pressure positive pressure ventilation can cause acute right heart failure, worsening venous congestion. Finally, in cases of refractory hypoxaemia, prone positioning is recommended by the European Society of Intensive Care Medicine following the publication of the French PROSEVA study. The feasibility of measuring venous congestion using VEXUS in the prone position has not been evaluated. Analysis of femoral venous flow or even popliteal venous flow could be useful in this situation.
............................................................................................................................................................................................................................................................................2) SUMMARY OF EXPECTED AND KNOWN BENEFITS AND RISKS : The research procedure consists of an abdominal venous ultrasound (inferior vena cava, portal vein, suprahepatic vein and renal vein) to calculate the VEXUS score, and a venous ultrasound of the lower limbs (femoral vein and popliteal vein). This procedure will be performed at the same time as the cardiac ultrasound (using the same equipment), which is a routine examination.
This is a non-invasive, non-irradiating examination that has been proven to be safe. There are therefore no risks associated with the research.
The expected benefit is collective:
In addition, the ultrasound protocol used could enable early diagnosis of venous thrombosis (suprahepatic, portal, renal, femoral or popliteal), thereby helping to improve patient care.
98 studies on the registry are indexed under Hyperemia; 44 are open to participants now.
This study's planned enrollment of 525 is above the median of 68 across 51 interventional studies indexed under Hyperemia.
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Non-inclusion criteria :
Exclusion Criteria:
- Portal vein, suprahepatic or femoral vein thrombosis at the time of ultrasound examination.
Every adult patients admitted to a medical intensive care unit (Besançon Teaching Hospital, Besançon, FRANCE) for any reason.
Procedure: Venous ultrasound (inferior vena cava, portal vein, suprahepatic vein, and renal vein to calculate the VEXUS score ; femoral vein and popliteal vein)
The research procedure consists of an abdominal venous ultrasound (inferior vena cava, portal vein, suprahepatic vein and renal vein) to calculate the VEXUS score, and a venous ultrasound of the lower limbs (femoral vein and popliteal vein). This procedure will be performed at the same time as the cardiac ultrasound (using the same equipment), which is a routine examination. This is a non-invasive, non-irradiating examination that has been proven to be safe. There are therefore no risks associated with the research.
Distribution of the VEXUS score among all patients admitted (for any reason) in a general intensive care unit
Describe the distribution of the VEXUS score among all patients admitted (for any reason) in a general intensive care unit at Besançon Teaching Hospital (Besançon, city, FRANCE).
Time frame: From the inclusion of the first patient to the 525th patient (approximately 9 months)
Feasability of VEXUS score measurement in prone position
\- Assess the failure rate of the VEXUS score measurement in prone position (proportion of patients included in whom a VEXUS score value in prone position could not be obtained by the operator in less than 10 minutes).
Time frame: From the inclusion of the first patient to the 525th patient (approximately 9 months)
Feasability of femoral venous flow measurement in supine and prone position
\- Assess the failure rate of femoral venous flow measurement in the supine position and in the prone positioning (proportion of patients included in whom femoral venous flow measurement in the supine position and the prone position could not be obtained by the operator in less than 10 minutes).
Time frame: From the inclusion of the first patient to the 525th patient (approximately 9 months)
Feasability of popliteal venous flow measurement in supine and prone position
\- Assess the failure rate of popliteal venous flow measurement in the supine position and in prone positioning (proportion of patients included in whom popliteal venous flow measurement in the supine position and the prone position could not be obtained by the operator in less than 10 minutes).
Time frame: From the inclusion of the first patient to the 525th patient (approximately 9 months)
VEXUS score evolution before, during and after prone positioning for ARDS
\- Describe the change in the VEXUS score (ranging from 0 (no congestion) to 3 (severe congestion)) before, during, and after the first prone position session in ARDS patients.
Time frame: From the inclusion of the first patient to the 525th patient (approximately 9 months)
Femoral venous flow evolution before, during and after prone positioning for ARDS
\- Describe the evolution of femoral venous flow (laminar (no congestion), or biphasic (severe congestion)) before, during, and after the first prone position session in ARDS patients.
Time frame: From the inclusion of the first patient to the 525th patient (approximately 9 months)
Popliteal venous flow evolution before, during and after prone positioning for ARDS
Describe the evolution of popliteal venous flow (laminar (no congestion), or biphasic (severe congestion)) before, during, and after the first prone position session in ARDS patients.
Time frame: From the inclusion of the first patient to the 525th patient (approximately 9 months)
Correlation between the VEXUS score and the pattern of femoral venous flow
\- Assess the correlation between the VEXUS score and the pattern of femoral venous flow (laminar of biphasic).
Time frame: From the inclusion of the first patient to the 525th patient (approximately 9 months)
Correlation between the VEXUS score and popliteal venous flow pattern
Assess the correlation between the VEXUS score and the pattern of popliteal venous flow (laminar of biphasic).
Time frame: From the inclusion of the first patient to the 525th patient (approximately 9 months)
Correlation between femoral and popliteal venous flow patterns
\- Assess the correlation between the pattern of femoral venous flow (laminar of biphasic) and the pattern of popliteal venous flow (laminar of biphasic).
Time frame: From the inclusion of the first patient to the 525th patient (approximately 9 months)
Started Mar 2026 (actual). Primary completion is estimated for Mar 2027, 12 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 27, 2026: primary completion Oct 2026 → Mar 2027 and completion Oct 2026 → Mar 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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