Clinical trial NCT06772038: Fluid Responsiveness and Venous Congestion Evolution During Volume Expansion
Official title: Dynamic Assessment of Fluid Responsiveness and Venous Congestion: Evolution of the VExUS Score During Volume Expansion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hemodynamic
Fluid Responsiveness
Venous Congestion
Fluid Challenge
Lead sponsor: Bicetre Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Longgang District People's Hospital of Shenzhen
First posted: 2025-01-13
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: The difference in venous congestion (VExUS) changes between fluid responders and non-responders following a fluid challenge.
timeFrame: before and after 15-minute fluid challenge.
Secondary outcomes:
measure: The differential evolution of venous congestion (VExUS) changes between fluid responders and non-responders 1 hour after a fluid challenge.
timeFrame: 1 hour after fluid challenge
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First affiliated Hospital , Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: Longgang Central Hospital of Shenzhen
state: Guangdong
city: Paris
country: France
facility: Bicetre Hospital
state: Val-de-Marne
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.