Timing of Preload Responsiveness in Sepsis

NCT ID: NCT05627817

Last Updated: 2022-11-28

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-20

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

During acute circulatory failure, volume expansion does not always lead to a significant increase in cardiac output (fluid responsiveness). After initial resuscitation by rapid fluid administration, cardiac preload is no longer extremely low and only half of the patients respond to further volume expansion with the expected increase in cardiac output (fluid unresponsiveness). However, the time delay or the volume of fluid needed to be administered from the state of fluid responsiveness to fluid unresponsiveness is still not determined.

Objective To determine, in critically ill patients with acute circulatory failure,

1. : the time and/or the volume of fluid needed from the state of fluid responsiveness to fluid unresponsiveness during septic shock.
2. : determine the factors that influence this time and volume.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Septic Shock Fluid Responsiveness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age ≥ 18 ans
* Onset of septic shock

Exclusion Criteria

* Planned to transfer the patient to another healthcare facility (inability to continue cardiac output measurements); urgent operation; Inability to measure the cardiac output.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Bicetre Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Xavier Monnet

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bicetre Hospital

Paris, Val-de-Marne, France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Rui SHI, M.D., Ph.D.

Role: CONTACT

+33642170297

Xavier MONNET, M.D.,Ph.D.

Role: CONTACT

+33145213539

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Xavier Monnet, MD. PhD

Role: primary

331 45 21 35 39

References

Explore related publications, articles, or registry entries linked to this study.

Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.

Reference Type BACKGROUND
PMID: 34599691 (View on PubMed)

Monnet X, Teboul JL. My patient has received fluid. How to assess its efficacy and side effects? Ann Intensive Care. 2018 Apr 24;8(1):54. doi: 10.1186/s13613-018-0400-z.

Reference Type BACKGROUND
PMID: 29691755 (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)

Roger C, Zieleskiewicz L, Demattei C, Lakhal K, Piton G, Louart B, Constantin JM, Chabanne R, Faure JS, Mahjoub Y, Desmeulles I, Quintard H, Lefrant JY, Muller L; AzuRea Group. Time course of fluid responsiveness in sepsis: the fluid challenge revisiting (FCREV) study. Crit Care. 2019 May 16;23(1):179. doi: 10.1186/s13054-019-2448-z.

Reference Type BACKGROUND
PMID: 31097012 (View on PubMed)

Kattan E, Ospina-Tascon GA, Teboul JL, Castro R, Cecconi M, Ferri G, Bakker J, Hernandez G; ANDROMEDA-SHOCK Investigators. Systematic assessment of fluid responsiveness during early septic shock resuscitation: secondary analysis of the ANDROMEDA-SHOCK trial. Crit Care. 2020 Jan 23;24(1):23. doi: 10.1186/s13054-020-2732-y.

Reference Type BACKGROUND
PMID: 31973735 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-A03040-55

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fluid Resuscitation in Early Septic Shock
NCT00819416 COMPLETED PHASE2
Early Vasopressors in Sepsis
NCT05179499 RECRUITING PHASE3