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

Not yet recruiting

• Conditions: Volume Expander
• Interventions: Procedure: Cardiac ultrasound; Procedure: Lung ultrasound

• Registration Number: NCT06415916
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-13
• Study First Submitted QC: 2024-05-13
• Last Update Submitted: 2024-05-13
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16
• Study Start: 2024-06
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patient	Cardiac ultrasound	Patients admitted to intensive care who require volume expander
patient	Lung ultrasound	Patients admitted to intensive care who require volume expander

Primary Outcome Measures

Name	Time	Method
the variation in the VExUs score during passive leg raising	Through study completion, on average of 2 hours	The 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

Trial Locations

Locations (1)

Chu Dijon Bourgogne; 🇫🇷 Dijon, France