Fluid Responsiveness and Venous Congestion Evolution During Volume Expansion

Recruiting

• Conditions: Hemodynamic; Fluid Responsiveness; Venous Congestion; Fluid Challenge

• Registration Number: NCT06772038
• Lead Sponsor: Bicetre Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2025-01-05
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference in venous congestion (VExUS) changes between fluid responders and non-responders following a fluid challenge.	before and after 15-minute fluid challenge.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

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

Bicetre Hospital; 🇫🇷 Paris, Val-de-Marne, France

Longgang Central Hospital of Shenzhen; 🇨🇳 Shenzhen, Guangdong, China