Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411080
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-08
Brief Title:
UltraSound Evaluation of Fluid tOleRanCE for Acute Kidney Injury
Sponsor:
Centre hospitalier de lUniversité de Montréal CHUM
Organization:
Centre hospitalier de lUniversité de Montréal CHUM
Study Overview
Official Title:
UltraSound Evaluation of Fluid tOleRanCE for Acute Kidney Injury A Pilot Randomized Controlled Trial
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:
USE-the-FORCE
Brief Summary:
Fluid expansion with isotonic crystalloids is a first-line intervention in the treatment of patients with acute kidney injury AKI While it is generally accepted that the timely correction of kidney hypoperfusion will minimize the extent of injury as well as potentially facilitate recovery there are potential harms involved in indiscriminate administration of intravenous fluids Although anticipating fluid tolerance is part of the clinical evaluation of a patient for whom intravenous fluid therapy is considered it has been suggested that using Point-Of-Care ultrasound POCUS may enable the early identification of patients with a high-risk of congestive complications and guide clinical decisions with greater precision1 However it has not been shown that providing this information in the context of AKI result in a change in management or a prevention of complications
This single-center pilot randomized controlled trial aim to determine the feasibility of comparing a management including a POCUS evaluation of fluid tolerance to usual care in non-critically ill patients with AKI In the intervention group a POCUS evaluation will be performed and interpreted by experienced staff producing a report that will be presented to the attending care team This assessment will be repeated 48-72 hours later The primary aim of the study will be to establish the feasibility of this intervention Secondary objectives will include determining the difference between the intervention arm and the control arm in relationship with fluid administration diuretic use evolution of kidney function and intensification of care
This single-center pilot randomized controlled trial aim to determine the feasibility of comparing a management including a POCUS evaluation of fluid tolerance to usual care in non-critically ill patients with AKI In the intervention group a POCUS evaluation will be performed and interpreted by experienced staff producing a report that will be presented to the attending care team This assessment will be repeated 48-72 hours later The primary aim of the study will be to establish the feasibility of this intervention Secondary objectives will include determining the difference between the intervention arm and the control arm in relationship with fluid administration diuretic use evolution of kidney function and intensification of care
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