NCT07438015

Brief Summary

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:

  • To study the feasibility of measuring the VEXUS score in patients with ARDS, including during prone positioning, a recommended and frequently used treatment for this condition, which could make it difficult to acquire venous ultrasound data.
  • In this case, other more accessible venous flows could be analysed, namely the femoral venous flow and the popliteal venous flow. We will therefore also study their feasibility during prone positioning sessions.
  • Subsequently, we will study the correspondence between the VEXUS score and these other types of venous flow (femoral, popliteal).
  • Finally, we will evaluate the association between the VEXUS score in our general intensive care population and the long-term prognosis of patients, in this case death on day 28 and the occurrence of acute renal failure requiring renal replacement therapy during the intensive care stay.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
525

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Mar 2026Oct 2026

First Submitted

Initial submission to the registry

December 29, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

February 27, 2026

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

December 29, 2025

Last Update Submit

February 20, 2026

Conditions

Keywords

VExUS scorevenous congestionfemoral venous flowpopliteal venous flow

Outcome Measures

Primary Outcomes (1)

  • 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).

    From the inclusion of the first patient to the 525th patient (approximately 9 months)

Secondary Outcomes (9)

  • Feasability of VEXUS score measurement in prone position

    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

    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

    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

    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

    From the inclusion of the first patient to the 525th patient (approximately 9 months)

  • +4 more secondary outcomes

Study Arms (1)

Every adult patients admitted to a medical intensive care unit for any reason

EXPERIMENTAL

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)

Interventions

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.

Every adult patients admitted to a medical intensive care unit for any reason

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted to medical intensive care at Besançon Teaching Hospital for any reason.
  • Aged over 18.
  • Affiliated with a French social security scheme or beneficiary of such a scheme.
  • No objection to participating in the study.
  • Minors
  • Pregnant women and breastfeeding mothers
  • Persons deprived of their liberty by judicial or administrative decision; persons undergoing compulsory psychiatric treatment; persons admitted to a health or social care institution for purposes other than research
  • Adults subject to legal protection measures or unable to give their consent
  • Subjects who are excluded from another study or listed in the 'national volunteer registry'.

You may not qualify if:

  • \- Portal vein, suprahepatic or femoral vein thrombosis at the time of ultrasound examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Jean MINJOZ

Besançon, 25000, France

Location

Related Publications (40)

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    BACKGROUND
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  • 32. Andrei S, Bahr PA, Nguyen M, Bouhemad B, Guinot PG. Prevalence of systemic venous congestion assessed by Venous Excess Ultrasound Grading System (VExUS) and association with acute kidney injury in a general ICU cohort: a prospective multicentric study. Crit Care Lond Engl. 8 juin 2023;27(1):224.

    BACKGROUND
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    BACKGROUND
  • 25. Beaubien-Souligny W, Bouchard J, Desjardins G, Lamarche Y, Liszkowski M, Robillard P, et al. Extracardiac Signs of Fluid Overload in the Critically Ill Cardiac Patient: A Focused Evaluation Using Bedside Ultrasound. Can J Cardiol. janv 2017;33(1):88-100.

    BACKGROUND
  • 24. Banjade P, Subedi A, Ghamande S, Surani S, Sharma M. Systemic Venous Congestion Reviewed. Cureus. août 2023;15(8):e43716.

    BACKGROUND
  • 23. Muñoz F, Born P, Bruna M, Ulloa R, González C, Philp V, et al. Coexistence of a fluid responsive state and venous congestion signals in critically ill patients: a multicenter observational proof-of-concept study. Crit Care Lond Engl. 19 févr 2024;28(1):52.

    BACKGROUND
  • 22. Monnet X, Shi R, Teboul JL. Prediction of fluid responsiveness. What's new? Ann Intensive Care. déc 2022;12(1):46.

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  • 21. De Backer D, Aissaoui N, Cecconi M, Chew MS, Denault A, Hajjar L, et al. How can assessing hemodynamics help to assess volume status? Intensive Care Med. oct 2022;48(10):1482-94.

    BACKGROUND
  • 20. Malbrain MLNG, Langer T, Annane D, Gattinoni L, Elbers P, Hahn RG, et al. Intravenous fluid therapy in the perioperative and critical care setting: Executive summary of the International Fluid Academy (IFA). Ann Intensive Care. 24 mai 2020;10(1):64.

    BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    BACKGROUND

MeSH Terms

Conditions

Hyperemia

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Hadrien WINISZEWSKI, MCU-PH

CONTACT

Valentin LAFAY, PHC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2025

First Posted

February 27, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

February 27, 2026

Record last verified: 2025-12

Locations