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Ultrasound and Clinical Approach for the Dynamic Assessment of Fluid Tolerance in the Intensive Care Unit

Ultrasound and Clinical Approach for the Dynamic Assessment of Fluid Tolerance in the Intensive Care Unit : FLUID-REACT Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06415916
Acronym
FLUID-REACT
Enrollment
100
Registered
2024-05-16
Start date
2024-03-15
Completion date
2028-03-01
Last updated
2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Volume Expander

Brief summary

A major cause of admission to intensive care is acute circulatory failure resulting from organ hypoperfusion due to factors such as hypotension and myocardial dysfunction. The standard treatment, including volume expansion and vasopressor/inotropic agents, often leads to water and sodium overload, increasing the risk of morbidity and mortality in the ICU. The combination of this overload and myocardial dysfunction lead to venous congestion, particularly affecting the lungs, kidneys and gastrointestinal system. Effective fluid management is therefore crucial to maintain a balance between adequate tissue perfusion and prevention of fluid overload. Fluid tolerance, defined as a patient's ability to tolerate additional volumes of solutes without adverse effects, is assessed retrospectively by clinical signs (capillary refill time, oedema, hepatojugular reflux, etc.) and ultrasound scores (VExUS score, LUS score, etc.). However, these indicators do not fully reflect the complexity of venous congestion in patients with various conditions. Assessing fluid tolerance remains a challenge in clinical practice. It requires a personalised approach and the use of dynamic tests such as passive leg raising to predict response to vascular filling. Despite their common use, there are no studies evaluating the ability of changes in congestion markers during passive leg raising to predict fluid tolerance. In conclusion, the main hypothesis is that changes in ultrasound congestion parameters (VExUS score, LUS score and others) during passive leg raising could predict a patient's subsequent tolerance to volume expander.

Interventions

Performed 5 times between 0 and 120 minutes

PROCEDURELung ultrasound

Performed 5 times between 0 and 120 minutes

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patient * Patient who has provided non-opposition (or health proxy or a close relative if unable to receive the information) * Patient admitted to intensive care and requiring volume expander

Exclusion criteria

* Person subject to a legal protection measure (curatorship, guardianship) * Person subject to a legal protection measure * Pregnant, parturient or breast-feeding women * Poor echogenicity assessed by the operator * Chronic AC/FA * Mechanical cardiac assistance

Design outcomes

Primary

MeasureTime frameDescription
the variation in the VExUs score during passive leg raisingThrough study completion, on average of 2 hoursThe VExUS score is calculated from ultrasound-doppler measurements of the inferior vena cava (IVC), suprahepatic venous flow (S wave, D wave), portal flow (continuous, pulsatile \>30%, pulsatile \>50%), renal venous flow (continuous, pulsatile biphasic, pulsatile monophasic). It is graded from 0 to 3

Countries

France

Contacts

CONTACTPierre-Grégoire GUINOT
pierregregoire.guinot@chu-dijon.fr0380281554

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026