Fluid Responsiveness and Venous Congestion Evolution During Volume Expansion

NCT ID: NCT06772038

Last Updated: 2025-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-05

Study Completion Date

2025-07-30

Brief Summary

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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

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Conditions

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Hemodynamic Fluid Responsiveness Venous Congestion Fluid Challenge

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fluid Responder

Patients with an aumentation of cardiac index\>= 15% after a fluid challenge

No interventions assigned to this group

Fluid Non-responder

Patients without an aumentation of cardiac index\>= 15% after a fluid challenge

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Longgang District People's Hospital of Shenzhen

OTHER

Sponsor Role collaborator

Bicetre Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xavier Monnet

Professor Xavier Monnet, MD, PHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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First affiliated Hospital , Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Longgang Central Hospital of Shenzhen

Shenzhen, Guangdong, China

Site Status RECRUITING

Bicetre Hospital

Paris, Val-de-Marne, France

Site Status RECRUITING

Countries

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China France

Central Contacts

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Xiang SI, MD

Role: CONTACT

0626824692 ext. 0626824692

Xavier MONNET, MD.PhD.

Role: CONTACT

+33 01 45 21 35 39

Facility Contacts

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Rui Shi

Role: primary

+86 13379192533

Ronglin Chen

Role: primary

+86 13510156528

Xavier Monnet, MD. PhD

Role: primary

331 45 21 35 39

Xavier Monnet, PHD, MD

Role: backup

Xiang SI, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 38374167 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35633423 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35729632 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36323911 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38671461 (View on PubMed)

Other Identifiers

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2022-A00580-43

Identifier Type: -

Identifier Source: org_study_id

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