Better Evidence for Selecting Transplant Fluids
A pragmatic, registry-based, double-blind, randomised controlled trial evaluating the effect of Plasmalyte versus 0.9% saline on early kidney transplant function in deceased donor kidney transplantation.
Principal Investigators: Dr Michael Collins and Professor Steve Chadban
Clinical Project Manager: Laura Robison (AKTN)
Clinical Research Associate: Julie Varghese (AKTN)
Trial Number: AKTN 15.02
Population: Adults and children with end-stage kidney disease receiving a deceased donor kidney transplant.
Intervention: Blinded intravenous Plasmalyte, or 0.9% saline (randomised 1:1), given for all fluid therapy purposes until 48 hours post-transplant.
Follow-up: 1 year
Primary outcome: Early kidney transplant function (composite of delayed graft function and rate of graft function recovery).
Status: Recruitment commenced in January 2018.
Target Recruitment: 574 participants across Australia and New Zealand.
End-stage kidney disease (ESKD) is a significant, expensive health problem. Kidney transplantation improves survival, quality of life, and is much cheaper than dialysis treatment for ESKD. However sometimes kidney transplants from a deceased donor function poorly after surgery, and a period of continued dialysis is needed, a condition known as delayed graft function (DGF). In addition to complicating recovery, DGF can adversely affect long-term kidney function and the health of the recipient.
Intravenous fluids given during and after transplantation (usually sodium chloride, or normal saline) are critical to preserve kidney transplant function, but there is evidence that saline may not be the safest fluid to use due to its high chloride content.
The BEST-Fluids trial aims to find out whether using a balanced low-chloride solution – Plasmalyte – as an alternative to normal saline in deceased donor kidney transplantation, will improve kidney transplant function, reduce the impact of DGF, and improve long-term outcomes for patients. Participants will be enrolled, randomised and followed up using ANZDATA, the Australia & New Zealand Dialysis & Transplant Registry.