Clinical trial NCT05627817: Timing of Preload Responsiveness in Sepsis
Official title: Timing of Preload Responsiveness in Sepsis and Septic Shock
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Septic Shock
Fluid Responsiveness
Lead sponsor: Bicetre Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
First posted: 2022-11-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The time delay from the state of fluid responsiveness to fluid unresponsiveness
timeFrame: 60 minutes after the evaluation of fluid responsiveness
measure: The volume of fluid needed from the state of fluid responsiveness to fluid unresponsiveness
timeFrame: 15-30 minutes during the fluid administration
Secondary outcomes:
measure: The risk factors for the time delay
timeFrame: Through study completion, an average of 1 year
measure: The risk factors for the volume of fluid needed from the state of fluid responsiveness to fluid
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Bicetre Hospital
state: Val-de-Marne
Study officials:
References:
citation: 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.
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.
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.
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.
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.