Timing of Preload Responsiveness in Sepsis

NCT05627817 | Unknown

• 1 other identifier: 2018-A03040-55
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Septic Shock; Fluid Responsiveness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• The risk factors for the time delay

  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

  Through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 18 ans
• Onset of septic shock

You may not qualify if:

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

Sponsors & Collaborators

• Bicetre Hospital: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (1)

Bicetre Hospital

Paris, Val-de-Marne, 94270, France

RECRUITING

Related 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.

  PMID: 34599691 BACKGROUND

• 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.

  PMID: 29691755 BACKGROUND

• 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.

  PMID: 35633423 BACKGROUND

• 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.

  PMID: 31097012 BACKGROUND

• 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.

  PMID: 31973735 BACKGROUND

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Central Study Contacts

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

CONTACT

+33642170297; shiruidingding@hotmail.com

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

CONTACT

+33145213539; xavier.monnet@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 28, 2022
• Study Start: February 20, 2019
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 28, 2022

Record last verified: 2022-11

Locations

FR (1)