Evaluation of the Venous Excess Ultrasound Score (VExUS) After Circulating Volume Modification in Children. (VExUS-Mod)

Evaluation of the Venous Excess Ultrasound Score (VExUS) After Circulating Volume Modification in Children. VExUS-Mod

Venous overload has an impact on peripheral organ perfusion and on the short- and long-term prognosis of intensive care patients. The VExUS ultrasound score is a new tool whose parameters can be used to estimate this impact. This score was initially evaluated and validated on an adult population. ) In children, there is only one study looking at the use and applicability of this VExUS score, highlighting its feasibility in a paediatric population, as well as a possible correlation between elevated central venous pressure and altered renal Doppler (one of the score's components).

Study Overview

• Status: Completed
• Conditions: Blood Volume Expansion
• Intervention / Treatment: Other: VExUS evaluation ultrasound

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31000
    • CHU Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All children aged between 1 and 18 years, receiving extrarenal purification with UF > 10 ml/kg, bleeding > 10 ml/kg or vascular filling > 10 ml/kg treated at Toulouse University Hospital.

Description

Inclusion Criteria:

Children aged between 1 and 18 years, receiving extrarenal purification with UF > 10 ml/kg, bleeding > 10 ml/kg or vascular filling > 10 ml/kg

Exclusion Criteria:

• Refusal of the patient or opposition of one or both holders of parental authority.
• Minors with parental authority.
• Ultrafiltration time > 6h.
• Curarized patient, known abnormality of the hepatorenal venous network.
• Patient agitated or poor tolerance of the examination.
• Parents under court protection, guardianship or curatorship.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Experimental; Patients over one year of age treated at Toulouse University Hospital and receiving extrarenal purification, bloodletting or vascular filling > 10 ml/kg.

Other: VExUS evaluation ultrasound; VExUS evaluation by ultrasound will be performed before the filling/bleeding/cleaning procedure, and again after the procedure: Inferior vena cava measurement in Time-Motion (TM) mode, 1-2 cm from the right atrial orifice.; Hepatic venous Doppler measurement in pulsed Doppler mode.; Renal vein Doppler measurement in pulsed Doppler mode. Each measurement is performed three times consecutively (to average the results), then the ultrasound measurements are compiled into a score according to the degree of doppler severity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in VExUS score	The correlation between ultrasound measurement of the VExUS score and the change in blood volume induced by extrarenal purification, bloodletting or vascular filling is studied. Ultrasound is performed before and after the procedure, each measure 3 times in succession, to establish the score.	10 minutes before en after the procedure of extrarenal purification, bloodletting or vascular filling

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Montserrat SIERRA COLOMINA, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Actual): June 6, 2025
• Study Completion (Actual): June 6, 2025

Study Registration Dates

• First Submitted: November 8, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Actual): November 19, 2024

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: bleeding; vascular filling; extra renal purification
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhage
• Other Study ID Numbers: RC31/24/0457

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No