Fluid Responsiveness and Venous Congestion Evolution During Volume Expansion

NCT06772038 | Recruiting

• 1 other identifier: 2022-A00580-43
• Study Type: observational
• Target: 64
• Locations: 2 countries
• Sites: 3

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.

Conditions

Hemodynamic; Fluid Responsiveness; Venous Congestion; Fluid Challenge

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Refusal to participate by relatives of the patient or the patient himself

Sponsors & Collaborators

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

Study Sites (3)

First affiliated Hospital , Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Longgang Central Hospital of Shenzhen

Shenzhen, Guangdong, 518116, China

RECRUITING

Bicetre Hospital

Paris, Val-de-Marne, 94270, France

RECRUITING

Related Publications (5)

• 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.

  PMID: 38374167 BACKGROUND

• 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.

  PMID: 35633423 BACKGROUND

• 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.

  PMID: 35729632 BACKGROUND

• 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.

  PMID: 36323911 BACKGROUND

• 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.

  PMID: 38671461 BACKGROUND

MeSH Terms

Conditions

Hyperemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Xiang SI, MD

CONTACT

0626824692; sixiang@mail.sysu.edu.cn

Xavier MONNET, MD.PhD.

CONTACT

+33 01 45 21 35 39; xavier.monnet@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Xavier Monnet, MD, PHD

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 13, 2025
• Study Start: January 5, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 30, 2025
• Last Updated: January 13, 2025

Record last verified: 2024-12

Locations

FR (1); CN (2)