ClinicalTrials.gg
RecruitingNCT06772038FREVOUpdated Jan 13, 2025

Fluid Responsiveness and Venous Congestion Evolution During Volume Expansion

An observational study in Hemodynamic, Fluid Responsiveness and Venous Congestion, sponsored by Bicetre Hospital. Recruiting at 3 sites in 2 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-01-13.

Sponsored by Bicetre Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
64
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hemodynamic
  • Fluid Responsiveness
  • Venous Congestion
  • Fluid Challenge

Browse trials for

03

In context

Hyperemia

98 studies on the registry are indexed under Hyperemia; 44 are open to participants now.

This study's planned enrollment of 64 is below the median of 100 across 46 observational studies indexed under Hyperemia.

Browse Hyperemia studies →

Lead sponsor

Bicetre Hospital is the lead sponsor of 25 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Pregnancy
  • Refusal to participate by relatives of the patient or the patient himself
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
64 participants (estimated)
Target follow-up
1 Month
Patient registry
Yes

Groups and cohorts

  • 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

06

What researchers measure

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

07

Study locations

3 of 3 sites recruiting
08

References and documents

Publications

  • 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. PubMed 38374167 ↗
  • 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. PubMed 35633423 ↗
  • 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. PubMed 35729632 ↗
  • 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. PubMed 36323911 ↗
  • 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. PubMed 38671461 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06772038
Lead sponsor
Bicetre Hospital
Collaborators
First Affiliated Hospital, Sun Yat-Sen University, Longgang District People's Hospital of Shenzhen
Responsible party
Xavier Monnet (Professor Xavier Monnet, MD, PHD, Bicetre Hospital) — Principal investigator
First posted
Jan 13, 2025
Start date
Jan 5, 2025 (estimated)
Primary completion
Jun 30, 2025 (estimated)
Completion
Jul 30, 2025 (estimated)
Last update
Jan 13, 2025

Study contacts

Xiang SI, MD
Contact
sixiang@mail.sysu.edu.cn
0626824692 ext. 0626824692
Xavier MONNET, MD.PhD.
Contact
xavier.monnet@aphp.fr
+33 01 45 21 35 39

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion