PROBE Fluid UK
Research type
Research Study
Full title
Proactive prescription-based fluid management vs usual care in critically ill patients on Kidney Replacement Therapy Trial in UK
IRAS ID
328763
Contact name
Marlies Ostermann
Contact email
Sponsor organisation
Guy's & St Thomas' NHS Foundation Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
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, patient's 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 single centre 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 also include short-term patient outcomes, safety outcomes, and health resource utilization related to KRT delivery.
During the 5-day period of the trial, we will also take a daily blood, urine and effluent fluid sample for special kidney tests to evaluate kidney health and recovery of kidney function.
REC name
London - Bromley Research Ethics Committee
REC reference
24/LO/0615
Date of REC Opinion
2 Oct 2024
REC opinion
Further Information Favourable Opinion