Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415916
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-13
Brief Title:
Ultrasound and Clinical Approach for the Dynamic Assessment of Fluid Tolerance in the Intensive Care Unit
Sponsor:
Centre Hospitalier Universitaire Dijon
Organization:
Centre Hospitalier Universitaire Dijon
Study Overview
Official Title:
Ultrasound and Clinical Approach for the Dynamic Assessment of Fluid Tolerance in the Intensive Care Unit FLUID-REACT Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
FLUID-REACT
Brief Summary:
A major cause of admission to intensive care is acute circulatory failure resulting from organ hypoperfusion due to factors such as hypotension and myocardial dysfunction The standard treatment including volume expansion and vasopressorinotropic agents often leads to water and sodium overload increasing the risk of morbidity and mortality in the ICU The combination of this overload and myocardial dysfunction lead to venous congestion particularly affecting the lungs kidneys and gastrointestinal system Effective fluid management is therefore crucial to maintain a balance between adequate tissue perfusion and prevention of fluid overload Fluid tolerance defined as a patients ability to tolerate additional volumes of solutes without adverse effects is assessed retrospectively by clinical signs capillary refill time oedema hepatojugular reflux etc and ultrasound scores VExUS score LUS score etc However these indicators do not fully reflect the complexity of venous congestion in patients with various conditions
Assessing fluid tolerance remains a challenge in clinical practice It requires a personalised approach and the use of dynamic tests such as passive leg raising to predict response to vascular filling Despite their common use there are no studies evaluating the ability of changes in congestion markers during passive leg raising to predict fluid tolerance
In conclusion the main hypothesis is that changes in ultrasound congestion parameters VExUS score LUS score and others during passive leg raising could predict a patients subsequent tolerance to volume expander
Assessing fluid tolerance remains a challenge in clinical practice It requires a personalised approach and the use of dynamic tests such as passive leg raising to predict response to vascular filling Despite their common use there are no studies evaluating the ability of changes in congestion markers during passive leg raising to predict fluid tolerance
In conclusion the main hypothesis is that changes in ultrasound congestion parameters VExUS score LUS score and others during passive leg raising could predict a patients subsequent tolerance to volume expander
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None