Timing of Preload Responsiveness in Sepsis

Septic Shock Clinical Trial

— TIPRES  

Official title:

Timing of Preload Responsiveness in Sepsis and Septic Shock

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05627817
• Other study ID #: 2018-A03040-55
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Fluid Responsiveness
• Septic Shock
• Shock, Septic

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