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

NCT06415916 | Recruiting

• 1 other identifier: GUINOT 2024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Volume Expander

Outcome Measures

Primary Outcomes (1)

• the variation in the VExUs score during passive leg raising

  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

  Through study completion, on average of 2 hours

Study Arms (1)

patient

Patients admitted to intensive care who require volume expander

Procedure: Cardiac ultrasound; Procedure: Lung ultrasound

Interventions

Cardiac ultrasound PROCEDURE

Performed 5 times between 0 and 120 minutes

patient

Lung ultrasound PROCEDURE

Performed 5 times between 0 and 120 minutes

patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients will be identified by the investigator on admission to the intensive care unit.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

RECRUITING

Central Study Contacts

Pierre-Grégoire GUINOT

CONTACT

0380281554; pierregregoire.guinot@chu-dijon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 16, 2024
• Study Start: March 15, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

FR (1)