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NCT Number: NCT06772038

Fluid Responsiveness and Venous Congestion Evolution During Volume Expansion

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.

Recruiting

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First affiliated Hospital , Sun Yat-sen University, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

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

    Time frame: 1 hour after fluid challenge

Study contacts

Contact information is provided by the study sponsor or research team.

Xavier MONNET, MD.PhD.

CONTACT

[email protected]

+33 01 45 21 35 39

Xiang SI, MD

CONTACT

[email protected]

0626824692 ext. 0626824692

Sponsors and collaborators

Lead sponsor

Bicetre Hospital

Other

Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University
  • Longgang District People's Hospital of Shenzhen

Registry information

Official study title

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

Acronym: FREVO

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2025
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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