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Clinical Trials in France / NCT06415916
Recruiting Observational

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

NCT06415916 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-03-15
Last updated
2026-02-12

Condition(s) studied

Volume Expander

Investigational drug(s) / intervention(s)

Cardiac ultrasoundLung ultrasound

Cardiac ultrasound: Performed 5 times between 0 and 120 minutes

Lung ultrasound: Performed 5 times between 0 and 120 minutes

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Chu Dijon Bourgogne Dijon France Recruiting

More Centre Hospitalier Universitaire Dijon trials in France

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06415916 on ClinicalTrials.gov ↗ ← All trials in France