Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT04283851
Status:
COMPLETED
Last Update Posted:
2023-03-07
First Post:
2020-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dynamic Parameters in Evaluation of Fluid Responsiveness
Sponsor:
Charles University, Czech Republic
Organization:
Study Overview
Official Title:
Dynamic Parameters in Evaluation of Fluid Resposiveness in Cardiac Surgery Patients in the Early Postoperative Period
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Intravenous infusion of fluids in patients after surgery is a very important part of treatment. However, administering too much or too little fluid can lengthen the stay in the intensive care unit or even harm the patient. Therefore, fluid therapy should be tailored to the individual needs of each patient. Several methods are available to assess which patients will likely benefit from fluid administration. However, each of these methods is useful only under certain conditions. The study aims to explore some less-known, yet promising tests which could make adequate fluid administration more precise and easier to achieve.
Detailed Description:
Adequate fluid therapy is one of the most important variables influencing patient outcome in intensive care. Fluid therapy should be tailored to the individual needs of each patient. Static parameters of preload have proved to be of little predictive value, therefore dynamic parameters are preferred for prediction of fluid responsiveness. Ideally, the cardiac output increases by 10% after a standardised fluid challenge. There are several methods already available to differentiate fluid-responsive from fluid-unresponsive patients, most notably the passive leg-raise. However, each of these methods has its own set of indications and contraindications. Also, a combination of tests could guide clinician´s decision in cases where the results of a single test are not entirely conclusive. Therefore, it would be desirable to add some less-known methods for prediction of fluid responsiveness, like the end-expiratory and end-inspiratory occlusion tests along with the assessment of diastolic properties of cardiac ventricles.
The aims of the study are:
* to determine the optimal increase in LVOT VTi to reliably predict fluid responsiveness
* to explore the accuracy of echocardiographic LVOT VTi evaluation during end-expiratory and end-inspiratory occlusion tests and their combination
* to assess the difference in echocardiographic properties of cardiac ventricles in fluid-responsive and fluid-unresponsive patients
* to compare the prediction based on echocardiography with the response to a standardised fluid challenge
* to assess the feasibility and practicality of echocardiographic monitoring in anesthetised cardiac surgery patients in intensive care
The aims of the study are:
* to determine the optimal increase in LVOT VTi to reliably predict fluid responsiveness
* to explore the accuracy of echocardiographic LVOT VTi evaluation during end-expiratory and end-inspiratory occlusion tests and their combination
* to assess the difference in echocardiographic properties of cardiac ventricles in fluid-responsive and fluid-unresponsive patients
* to compare the prediction based on echocardiography with the response to a standardised fluid challenge
* to assess the feasibility and practicality of echocardiographic monitoring in anesthetised cardiac surgery patients in intensive care
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: