Timing of Preload Responsiveness in Sepsis

Recruiting

• Conditions: Septic Shock; Fluid Responsiveness

• Registration Number: NCT05627817
• Lead Sponsor: Bicetre Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-20
• Status Verified: 2022-11
• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-11-22
• Last Update Submitted: 2022-11-22
• Study First Posted: 2022-11-28
• Last Update Posted: 2022-11-28
• Primary Completion: 2023-06
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The volume of fluid needed from the state of fluid responsiveness to fluid unresponsiveness	15-30 minutes during the fluid administration	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.
The time delay from the state of fluid responsiveness to fluid unresponsiveness	60 minutes after the evaluation of fluid responsiveness	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.

Secondary Outcome Measures

Name	Time	Method
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	Determine the factors that may influence the volume of fluid administrated from the state of fluid responsiveness to fluid unresponsiveness
The risk factors for the time delay	Through study completion, an average of 1 year	Determine the factors that may influence the time delay from the state of fluid responsiveness to fluid unresponsiveness

Trial Locations

Locations (1)

Bicetre Hospital; 🇫🇷 Paris, Val-de-Marne, France