Ignite Creation Date:
2024-07-17 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471777
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-18
Brief Title:
Prescription-based Fluid Management Versus Usual Care in Critically Ill Patients on KRT Trial in UK
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
Proactive Prescription-based Fluid Management Versus Usual Care in Critically Ill Patients on Kidney Replacement Therapy Trial in UK
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
PROBE Fluid UK
Brief Summary:
The PROBE Fluid UK randomised controlled trial compares a protocol-based fluid removal strategy with usual care in critically ill patients with acute kidney injury receiving kidney replacement therapy
Detailed Description:
Severe acute kidney injury AKI in the intensive care unit ICU is almost uniformly complicated by fluid accumulation often leading to fluid overload Congestion resulting from fluid accumulation is believed to contribute to organ failure Removal of excess fluid is a central component of dialysis treatment also known as kidney replacement therapy KRT However there remain important knowledge gaps in our ability to remove excess fluid effectively and safely If fluid is removed too slowly fluid overload and its complications persist for longer If fluid is removed too fast during KRT patients blood pressure may drop ie hemodynamic instability may occur which may precipitate complications
The optimal fluid management strategy is currently unknown
The PROBE Fluid UK study is a randomized clinical trial comparing a protocol-based fluid removal strategy with usual care in critically ill patients with AKI receiving KRT The fluid management protocol is intended to achieve neutral or negative daily fluid balance by both preventing and treating fluid accumulation
The primary objective of this trial is to determine whether the intervention results in a difference in cumulative fluid balance from day of randomization to 5 days later Secondary outcomes will include short-term patient outcomes safety outcomes and health resource utilization related to KRT delivery
The optimal fluid management strategy is currently unknown
The PROBE Fluid UK study is a randomized clinical trial comparing a protocol-based fluid removal strategy with usual care in critically ill patients with AKI receiving KRT The fluid management protocol is intended to achieve neutral or negative daily fluid balance by both preventing and treating fluid accumulation
The primary objective of this trial is to determine whether the intervention results in a difference in cumulative fluid balance from day of randomization to 5 days later Secondary outcomes will include short-term patient outcomes safety outcomes and health resource utilization related to KRT delivery
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