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Clinical Trials/NCT06772038
NCT06772038
Recruiting
N/A

Dynamic Assessment of Fluid Responsiveness and Venous Congestion: Evolution of the VExUS Score During Volume Expansion

Bicetre Hospital3 sites in 2 countries64 target enrollmentJanuary 5, 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Fluid Challenge
Sponsor
Bicetre Hospital
Enrollment
64
Locations
3
Primary Endpoint
The difference in venous congestion (VExUS) changes between fluid responders and non-responders following a fluid challenge.
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Fluid responsiveness is a critical determinant guiding fluid therapy in critically ill patients. However, excessive fluid administration can result in fluid overload, leading to venous congestion and worse clinical outcomes. Venous congestion, a marker of impaired fluid clearance, is increasingly recognized as a significant contributor to poor prognosis. Previous studies have demonstrated the coexistence of fluid responsiveness and venous congestion in critically ill patients. Notably, these studies were limited by the absence of fluid challenge-the gold standard for assessing fluid responsiveness-leaving the dynamic relationship between fluid responsiveness and venous congestion incompletely understood. This study aims to investigate the interplay and temporal evolution of fluid responsiveness and venous congestion following a standardized fluid challenge in critically ill patients.

Registry
clinicaltrials.gov
Start Date
January 5, 2025
End Date
July 30, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Bicetre Hospital
Responsible Party
Principal Investigator
Principal Investigator

Xavier Monnet

Professor Xavier Monnet, MD, PHD

Bicetre Hospital

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years
  • Hospitalized in the intensive care unit (ICU)
  • Hemodynamic monitoring in place, with a pulse wave contour analysis- derived estimation of cardiac output (either calibrated or uncalibrated)
  • Decision made by clinicians to perform volume expansion through intravenous infusion of crystalloid fluid

Exclusion Criteria

  • Pregnancy
  • Refusal to participate by relatives of the patient or the patient himself

Outcomes

Primary Outcomes

The difference in venous congestion (VExUS) changes between fluid responders and non-responders following a fluid challenge.

Time Frame: before and after 15-minute fluid challenge.

Secondary Outcomes

  • The differential evolution of venous congestion (VExUS) changes between fluid responders and non-responders 1 hour after a fluid challenge.(1 hour after fluid challenge)

Study Sites (3)

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