Timing of Preload Responsiveness in Sepsis (TIPRES)

Timing of Preload Responsiveness in Sepsis and Septic Shock

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.

Study Overview

• Status: Recruiting
• Conditions: Septic Shock; Fluid Responsiveness

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Rui SHI, M.D., Ph.D.; Phone Number: +33642170297; Email: shiruidingding@hotmail.com
• Study Contact Backup: Name: Xavier MONNET, M.D.,Ph.D.; Phone Number: +33145213539; Email: xavier.monnet@aphp.fr

Study Locations

• France
  • Val-de-Marne
    • Paris, Val-de-Marne, France, 94270
      • Recruiting
      • Bicetre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patients who just arrive at the Intensive Care Unit (ICU) for septic shock need to be quickly resuscitated.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Bicetre Hospital
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2019
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 22, 2022
• First Posted (Actual): November 28, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Sepsis; Shock, Septic
• Other Study ID Numbers: 2018-A03040-55

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No