ANZICS CTG Supported Study
ProBeFluid KRT
Pilot open-label trial of protocol-based fluid removal vs usual care in critically ill patients on kidney replacement therapy
Study Description
Severe acute kidney injury (AKI) in the intensive care unit (ICU) is almost uniformly complicated by fluid accumulation, thus making fluid removal a central component of the renal replacement therapy (KRT) prescription. Whereas the achievement and maintenance of euvolemia are critical objectives in the care of critically ill patients with severe AKI, there remain important knowledge gaps in our ability to effectively and safely deliver ultrafiltration. Multisystemic congestion resulting from fluid accumulation is believed to mediate adverse outcomes in this population and the timely use of mechanical fluid removal may improve prognosis. However, fluid removal may be associated with hemodynamic instability during KRT which may precipitate complications. The optimal fluid management strategy is currently unknown.
We propose a pilot randomized clinical trial comparing a protocol-based fluid management strategy, aimed to achieve neutral or negative daily fluid balance, with usual care in critically ill patients receiving KRT. The fluid management protocol was designed to provide a standardized framework to prescribe fluid removal while allowing the attending care team to modify treatment targets according to their clinical evaluation.
The primary objective of this trial will be to determine feasibility including protocol adherence, ability to enroll, the capacity to achieve follow-up through 90 days, and whether there is evidence of a significant difference in daily fluid balance between groups. Secondary outcomes will include short-term patient outcomes, safety outcomes, and health resource utilization related to KRT delivery.
The success of the ProBeFluid-KRT trial will lay the groundwork for a definitive trial to evaluate whether a protocolized fluid management strategy can improve patient-centered outcomes, including reduced mortality and shorter duration of organ support, compared to usual care. Defining the optimal fluid management strategy for critically ill patients receiving treatment with KRT represents an urgent priority to ameliorate the dismal prognosis in this population with a well-documented short-term mortality rate of more than 40%.
Steering Committee
William Beaubien-Souligny MD PhD, Université de Montréal, Qc, Canada, Ron Wald MDCM, MPH, St. Michael’s hospital, Toronto, Canada, Sean M. Bagshaw, MD MSc, University of Alberta, Edmonton Canada, Rinaldo Bellomo AO MBBS MD FRACP FCICM FAHMS, University of Melbourne, Melbourne, Australia, Neill KJ Adhikari MD MSc, Sunnybrook Health Sciences Centre, Toronto, Canada, Martin Gallagher MBBS, MPH (Hons), PhD George Institute for Global Health, University of Sydney, Australia
Administering Institution
Division of Nephrology, Centre Hospitalier de l’Université de Montréal
Sample Size
150 patients
Funding
tba
Reference
CTG 2122-04
Contact
Rinaldo Bellomo (email)