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Timing of Preload Responsiveness in Sepsis

Timing of Preload Responsiveness in Sepsis and Septic Shock

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05627817
Acronym
TIPRES
Enrollment
100
Registered
2022-11-28
Start date
2019-02-20
Completion date
2023-12-31
Last updated
2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Responsiveness, Septic Shock

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.

Interventions

None listed

Sponsors

First Affiliated Hospital, Sun Yat-Sen University
CollaboratorOTHER
Bicetre Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The time delay from the state of fluid responsiveness to fluid unresponsiveness60 minutes after the evaluation of fluid responsivenessAt 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.
The volume of fluid needed from the state of fluid responsiveness to fluid unresponsiveness15-30 minutes during the fluid administrationIf 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.

Secondary

MeasureTime frameDescription
The risk factors for the time delayThrough study completion, an average of 1 yearDetermine the factors that may influence the time delay from the state of fluid responsiveness to fluid unresponsiveness
The risk factors for the volume of fluid needed from the state of fluid responsiveness to fluidThrough study completion, an average of 1 yearDetermine the factors that may influence the volume of fluid administrated from the state of fluid responsiveness to fluid unresponsiveness

Countries

France

Contacts

Primary ContactRui SHI, M.D., Ph.D.
shiruidingding@hotmail.com+33642170297
Backup ContactXavier MONNET, M.D.,Ph.D.
xavier.monnet@aphp.fr+33145213539

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026