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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05627817
Other study ID # 2018-A03040-55
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 20, 2019
Est. completion date December 2023

Study information

Verified date November 2022
Source Bicetre Hospital
Contact Rui SHI, M.D., Ph.D.
Phone +33642170297
Email shiruidingding@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Bicetre Hospital Paris Val-de-Marne

Sponsors (2)

Lead Sponsor Collaborator
Bicetre Hospital First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

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. — View 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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The time delay from the state of fluid responsiveness to fluid unresponsiveness At the time of inclusion, the investigators use the tests available (fluid challenge, passive leg raising, end-expiratory occlusion test) to evaluate the presence of fluid responsiveness, and after one hour, the investigators repeat the test and to re-evaluate the presence of fluid responsiveness until the patient is no longer present the fluid responsiveness. 60 minutes after the evaluation of fluid responsiveness
Primary The volume of fluid needed from the state of fluid responsiveness to fluid unresponsiveness If the fluid challenge is performed, the volume of each time for the fluid administration should be noted until the patient is no longer fluid-responsive, then the investigators can calculate the total amount of the fluid administrated. 15-30 minutes during the fluid administration
Secondary The risk factors for the time delay Determine the factors that may influence the time delay from the state of fluid responsiveness to fluid unresponsiveness Through study completion, an average of 1 year
Secondary The risk factors for the volume of fluid needed from the state of fluid responsiveness to fluid Determine the factors that may influence the volume of fluid administrated from the state of fluid responsiveness to fluid unresponsiveness Through study completion, an average of 1 year
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