Fluid Responsiveness and Venous Congestion Evolution During Volume Expansion (FREVO)

Dynamic Assessment of Fluid Responsiveness and Venous Congestion: Evolution of the VExUS Score 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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 64

Contacts and Locations

• Study Contact: Name: Xiang SI, MD; Phone Number: 0626824692 0626824692; Email: sixiang@mail.sysu.edu.cn
• Study Contact Backup: Name: Xavier MONNET, MD.PhD.; Phone Number: +33 01 45 21 35 39; Email: xavier.monnet@aphp.fr

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • First affiliated Hospital , Sun Yat-sen University
      • Contact: Rui Shi; Phone Number: +86 13379192533; Email: rui.maya.shi@hotmail.com
    • Shenzhen, Guangdong, China, 518116
      • Recruiting
      • Longgang Central Hospital of Shenzhen
      • Contact: Ronglin Chen; Phone Number: +86 13510156528; Email: ronglinch@126.com
• France
  • Val-de-Marne
    • Paris, Val-de-Marne, France, 94270
      • Recruiting
      • Bicetre Hospital
      • Contact: Xavier Monnet, MD. PhD; Phone Number: 331 45 21 35 39; Email: xavier.monnet@aphp.fr
      • Contact: Xavier Monnet, PHD, MD
      • Contact: Xiang SI, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Critically ill patients with evidence of inadequate tissue perfusion, who are already monitored using a pulse wave contour analysis-derived estimation of cardiac output (either calibrated or uncalibrated)，and for whom clinicians have decided to administer volume expansion through intravenous crystalloid infusion.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Fluid Responder; Patients with an aumentation of cardiac index>= 15% after a fluid challenge
Fluid Non-responder; Patients without an aumentation of cardiac index>= 15% after a fluid challenge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bicetre Hospital
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; Longgang District People's Hospital of Shenzhen

Publications and helpful links

General Publications

• Monnet X, Shi R, Teboul JL. Prediction of fluid responsiveness. What's new? Ann Intensive Care. 2022 May 28;12(1):46. doi: 10.1186/s13613-022-01022-8.
• Munoz F, Born P, Bruna M, Ulloa R, Gonzalez C, Philp V, Mondaca R, Blanco JP, Valenzuela ED, Retamal J, Miralles F, Wendel-Garcia PD, Ospina-Tascon GA, Castro R, Rola P, Bakker J, Hernandez G, Kattan E. Coexistence of a fluid responsive state and venous congestion signals in critically ill patients: a multicenter observational proof-of-concept study. Crit Care. 2024 Feb 19;28(1):52. doi: 10.1186/s13054-024-04834-1.
• Messina A, Calabro L, Pugliese L, Lulja A, Sopuch A, Rosalba D, Morenghi E, Hernandez G, Monnet X, Cecconi M. Fluid challenge in critically ill patients receiving haemodynamic monitoring: a systematic review and comparison of two decades. Crit Care. 2022 Jun 21;26(1):186. doi: 10.1186/s13054-022-04056-3.
• Monnet X, Malbrain MLNG, Pinsky MR. The prediction of fluid responsiveness. Intensive Care Med. 2023 Jan;49(1):83-86. doi: 10.1007/s00134-022-06900-0. Epub 2022 Nov 3. No abstract available.
• Joseph A, Petit M, Vignon P, Vieillard-Baron A. Fluid responsiveness and venous congestion: unraveling the nuances of fluid status. Crit Care. 2024 Apr 26;28(1):140. doi: 10.1186/s13054-024-04930-2. No abstract available.

Study record dates

Study Major Dates

• Study Start (Estimated): January 5, 2025
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): July 30, 2025

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hyperemia
• Other Study ID Numbers: 2022-A00580-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No