BEST-Fluids

best-fluids-logo-2016

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.

AKTN response plan for novel coronavirus (COVID-19) – BEST-Fluids

In response to the COVID-19 pandemic and resultant burden on clinicians and the health system, the AKTN temporarily suspended recruitment of new patients as of Thursday 26 March 2020. With the improving situation with COVID-19 in Australia and New Zealand, the following actions have been taken:

  • Recommencement of recruitment of new patients: Recruitment recommenced at all sites in New Zealand. Recruitment is recommencing at Australian sites from 5 June onwards, once local governance approval has been received to do so at each site.
  • Sites with enrolled participants: Data collection to continue to the extent their individual circumstance and local restrictions allow.

The AKTN will continue to monitor the situation. We appreciate your commitment and valuable contribution to the BEST-Fluids trial.

Please contact the BEST-Fluids team if you would like to discuss further on bestfluids@uq.edu.au

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: Delayed graft function, defined as receiving treatment with any form of dialysis in the first seven days after transplant.
Status: Actively recruiting in New Zealand.
Target Recruitment: 800 participants across Australia and New Zealand.
Publications: Study protocol has now been published, results expected in 2022.  Read the full articles via the links below:
Full-text version at TRIALS journal website (Open Access) or in PDF Copy


Trial Summary

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.