Actively Recruiting

Age: 18Years - 99Years
All Genders
ID06772038

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

Led by Bicetre Hospital · Updated on 2025-01-13

64

Participants Needed

3

Research Sites

4 weeks

Total Duration

On this page

Sponsors

B

Bicetre Hospital

Lead Sponsor

F

First Affiliated Hospital, Sun Yat-Sen University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Fluid responsiveness is an important factor that helps guide fluid therapy in critically ill patients. This research aims to better understand the relationship between fluid responsiveness and venous congestion, a condition where excess fluid causes pressure in the veins and can lead to worse health outcomes. The study focuses on how these factors change over time after giving a standardized fluid challenge to patients in intensive care. Patients in the intensive care unit who are monitored for heart function and have a clinical decision to receive intravenous crystalloid fluid will be observed. The study groups include those whose cardiac index increases by 15% or more after the fluid challenge and those who do not show this increase. The main goal is to compare changes in venous congestion, measured by the VExUS score, between these two groups immediately after and one hour following the fluid challenge. Participants will be closely monitored with hemodynamic tools before and after fluid administration. Researchers will assess the VExUS score for venous congestion changes at baseline, after 15 minutes, and again one hour later. This will help understand how fluid responsiveness affects venous congestion over time. The study is observational and will last until July 2025, involving adult patients aged 18 to 99 years who are receiving fluid therapy in the ICU.

CONDITIONS

Brief Title

Fluid Responsiveness and Venous Congestion Evolution During Volume Expansion

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 63 18 years
  • Hospitalized in the intensive care unit (ICU)
  • Hemodynamic monitoring in place with pulse wave contour analysis-derived cardiac output estimation
  • Clinical decision to perform volume expansion via intravenous infusion of crystalloid fluid
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Refusal to participate by patient or their relatives

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 1 hour post fluid challenge

Participants are observed during and after a fluid challenge to assess fluid responsiveness and venous congestion changes.

1 visit including assessments before, immediately after, and 1 hour after the fluid challenge

Trial Site Locations

Total: 3 locations

1

First affiliated Hospital , Sun Yat-sen University

Guangzhou, Guangdong, China, 510080

Actively Recruiting

2

Longgang Central Hospital of Shenzhen

Shenzhen, Guangdong, China, 518116

Actively Recruiting

3

Bicetre Hospital

Paris, Val-de-Marne, France, 94270

Actively Recruiting

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Research Team

X

Xiang SI, MD

X

Xavier MONNET, MD.PhD.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Coexistence of a fluid responsive state and venous congestion signals in critically ill patients: a multicenter observational proof-of-concept study.

Felipe Muñoz, Pablo Born, Mario Bruna...

https://pubmed.ncbi.nlm.nih.gov/38374167

Fluid challenge in critically ill patients receiving haemodynamic monitoring: a systematic review and comparison of two decades.

Antonio Messina, Lorenzo Calabrò, Luca Pugliese...

https://pubmed.ncbi.nlm.nih.gov/35729632