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

NCT ID: NCT06415916

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-15

Study Completion Date

2026-03-31

Brief Summary

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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

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Conditions

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Volume Expander

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patient

Patients admitted to intensive care who require volume expander

Cardiac ultrasound

Intervention Type PROCEDURE

Performed 5 times between 0 and 120 minutes

Lung ultrasound

Intervention Type PROCEDURE

Performed 5 times between 0 and 120 minutes

Interventions

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Cardiac ultrasound

Performed 5 times between 0 and 120 minutes

Intervention Type PROCEDURE

Lung ultrasound

Performed 5 times between 0 and 120 minutes

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Dijon Bourgogne

Dijon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pierre-Grégoire GUINOT

Role: CONTACT

Phone: 0380281554

Email: [email protected]

Facility Contacts

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Pierre-Grégoire GUINOT

Role: primary

Other Identifiers

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GUINOT 2024

Identifier Type: -

Identifier Source: org_study_id