Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-26 @ 9:08 PM
Study NCT ID:
NCT07073859
Status:
COMPLETED
Last Update Posted:
2025-07-18
First Post:
2025-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluid Responsiveness Assessment in Children
Sponsor:
University Hospital, Bordeaux
Organization:
Study Overview
Official Title:
Fluid Responsiveness Assessment in Pediatric Intensive Care Units: a Nationwide Clinical Practice Analysis
Status:
COMPLETED
Status Verified Date:
2025-07
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:
FRAICHE
Brief Summary:
Fluid responsiveness assessment is a major issue in intensive care. Since fewer fluid responsiveness tests can be used children, fluid expansion prescriptions are often based on professional practices due to the absence of guidelines. This observational, cross-sectional, multicentric study is an evaluation of professional practices regarding fluid expansions in pediatric intensive care units. The main objective will be to describe the proportion of fluid expansions that are administered following an assessment of fluid responsiveness.
Detailed Description:
Fluid expansion is the cornerstone of acute circulatory failure treatment. Although this therapy drastically reduced mortality, several studies in recent years have highlighted the adverse effects of excessive fluid expansion (leading to fluid overload). Currently, the search for indicators to predict fluid responsiveness is a major issue in intensive care units (ICU). These indicators are based on Franck-Starling's law: if small changes in preload lead to an increase in cardiac output, then fluid responsiveness can be expected. This assessment is necessary but must be as simple as possible in an emergency setting such as ICU. Although several fluid responsiveness tests are available in adults, they are underused in current practice. In children, the only validated indicator (respiratory variability of peak aortic velocity) can only be used in the absence of any spontaneous respiratory movement, a rare situation in practice. Thus, fluid expansion prescriptions in pediatric ICU (PICU) are based on professional practices that are often heterogeneous due to the absence of evidence-based guidelines. An evaluation of professional practices is a first step towards standardizing practices.
This study is an evaluation of professional practices regarding fluid expansion in PICU. The main objective will be to describe the proportion of fluid expansions that are administered following an assessment of fluid responsiveness.
We will conduct an observational, cross-sectional, multicentric study in French PICU. Data will be collected retrospectively, after fluid expansion administration, by the prescribing physician through a electronic CRF (RedCAP). These data will be collected from standard monitoring and/or from the patient's medical record. Data will therefore only be collected at a single point in time.
This study is an evaluation of professional practices regarding fluid expansion in PICU. The main objective will be to describe the proportion of fluid expansions that are administered following an assessment of fluid responsiveness.
We will conduct an observational, cross-sectional, multicentric study in French PICU. Data will be collected retrospectively, after fluid expansion administration, by the prescribing physician through a electronic CRF (RedCAP). These data will be collected from standard monitoring and/or from the patient's medical record. Data will therefore only be collected at a single point in time.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CER-BDX 2024 - 31 | OTHER | Comité d'Ethique de la Recherche du Centre Ethique et Recherche en Santé de Bordeaux | View |