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Study Protocol for Better Evidence for Selecting Transplant Fluids (BEST-Fluids): a pragmatic, registry-based, multi-center, double-blind, randomized controlled trial evaluating the effect of intravenous fluid therapy with Plasma-Lyte 148 versus 0.9% saline on delayed graft function in deceased donor kidney transplantation.

Department of Renal Medicine, Auckland District Health Board, Auckland City Hospital, Auckland, New Zealand. michael.collins@adhb.govt.nz. Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand. michael.collins@adhb.govt.nz. Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia. michael.collins@adhb.govt.nz. Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia. Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia. Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry, South Australian Health and Medical Research Institute (SAHMRI), Adelaide, Australia. Department of Medicine, The University of Adelaide, Adelaide, Australia. Central and Northern Adelaide Renal and Transplantation Service, Royal Adelaide Hospital, Adelaide, Australia. Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia. Department of Critical Care Medicine, Auckland City Hospital, Auckland, New Zealand. Department of Nephrology, Austin Health, Melbourne, Australia. Department of Medicine (Austin), The University of Melbourne, Parkville, Melbourne, Australia. Department of Anaesthesia, Austin Health, Melbourne, Australia. Department of Surgery, Austin Health, The University of Melbourne, Melbourne, Australia. Department of Renal Medicine, Royal Prince Alfred Hospital, Sydney, Australia. Charles Perkins Centre, The University of Sydney, Sydney, Australia.

Trials. 2020;(1):428
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Abstract

BACKGROUND Delayed graft function, the requirement for dialysis due to poor kidney function post-transplant, is a frequent complication of deceased donor kidney transplantation and is associated with inferior outcomes and higher costs. Intravenous fluids given during and after transplantation may affect the risk of poor kidney function after transplant. The most commonly used fluid, isotonic sodium chloride (0.9% saline), contains a high chloride concentration, which may be associated with acute kidney injury, and could increase the risk of delayed graft function. Whether using a balanced, low-chloride fluid instead of 0.9% saline is safe and improves kidney function after deceased donor kidney transplantation is unknown. METHODS BEST-Fluids is an investigator-initiated, pragmatic, registry-based, multi-center, double-blind, randomized controlled trial. The primary objective is to compare the effect of intravenous Plasma-Lyte 148 (Plasmalyte), a balanced, low-chloride solution, with the effect of 0.9% saline on the incidence of delayed graft function in deceased donor kidney transplant recipients. From January 2018 onwards, 800 participants admitted for deceased donor kidney transplantation will be recruited over 3 years in Australia and New Zealand. Participants are randomized 1:1 to either intravenous Plasmalyte or 0.9% saline peri-operatively and until 48 h post-transplant, or until fluid is no longer required; whichever comes first. Follow up is for 1 year. The primary outcome is the incidence of delayed graft function, defined as dialysis in the first 7 days post-transplant. Secondary outcomes include early kidney transplant function (composite of dialysis duration and rate of improvement in graft function when dialysis is not required), hyperkalemia, mortality, graft survival, graft function, quality of life, healthcare resource use, and cost-effectiveness. Participants are enrolled, randomized, and followed up using the Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry. DISCUSSION If using Plasmalyte instead of 0.9% saline is effective at reducing delayed graft function and improves other clinical outcomes in deceased donor kidney transplantation, this simple, inexpensive change to using a balanced low-chloride intravenous fluid at the time of transplantation could be easily implemented in the vast majority of transplant settings worldwide. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry: ACTRN12617000358347. Registered on 8 March 2017. ClinicalTrials.gov: NCT03829488. Registered on 4 February 2019.