Blood Volume ExpansionVExUS-ModNCT06695546
Evaluation of the Venous Excess Ultrasound Score (VExUS) After Circulating Volume Modification in Children.
An observational study of Blood Volume Expansion, run by University Hospital, Toulouse at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Blood Volume Expansion
- What is being tested?
- VExUS evaluation ultrasound
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 10 Dec 2024to 6 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Blood Volume Expansion
- Being tested
- VExUS evaluation ultrasound
- Keywords
- extra renal purification, bleeding, vascular filling
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VExUS evaluation ultrasoundOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Patients over one year of age treated at Toulouse University Hospital and receiving extrarenal purification, bloodletting or vascular filling > 10 ml/kg. Receives: Other: VExUS evaluation ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes before en after the procedure of extrarenal purification, bloodletting or vascular filling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start10 Dec 2024
- Primary completion6 Jun 2025
- Study completion6 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Volume ExpansionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Montserrat SIERRA COLOMINA, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695546
- Sponsor's protocol ID
- RC31/24/0457
- Acronym
- VExUS-Mod
- Status last verified
- Jan 2026
- First submitted
- 8 Nov 2024
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Venous Excess Ultrasound Score (VExUS) After Circulating Volume Modification in Children. VExUS-Mod
- ClinicalTrials.gov ID
- NCT06695546
- Acronym / sponsor ID
- VExUS-Mod / RC31/24/0457
- Conditions
- Blood Volume Expansion
- Keywords
- extra renal purification, bleeding, vascular filling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Other: VExUS evaluation ultrasoundPatients over one year of age treated at Toulouse University Hospital and receiving extrarenal purification, bloodletting or vascular filling > 10 ml/kg. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VExUS evaluation ultrasoundVExUS 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. | Other | Experimental |
Primary outcome
Change in VExUS score
Time frame: 10 minutes before en after the procedure of extrarenal purification, bloodletting or vascular filling
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Montserrat SIERRA COLOMINA, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Volume Expansion, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VExUS score (time frame: 10 minutes before en after the procedure of extrarenal purification, bloodletting or vascular filling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.