Better Evidence for Selecting Transplant Fluids (BEST-Fluids)

Overview

Kidney transplantation is the best treatment for kidney failure, but when kidneys from deceased donors function poorly after surgery, patients may need temporary dialysis — a complication known as delayed graft function (DGF). DGF increases the risk of complications and can negatively affect long-term transplant outcomes. Intravenous fluids used during and after surgery play a key role in supporting the new kidney. While 0.9% saline is commonly used, its high chloride content may impair kidney recovery.

The BEST Fluids trial (Better Evidence for Selecting Transplant Fluids) tested whether using a balanced, low-chloride crystalloid solution (Plasma-Lyte 148) instead of saline improves outcomes after deceased donor kidney transplantation. In this pragmatic, registry-embedded, multicentre, double-blind, randomised controlled trial, 808 adult and paediatric recipients across 16 transplant centres in Australia and New Zealand were enrolled. The primary outcome was delayed graft function, with follow-up data collected via the ANZDATA Registry.

Principal Investigators:	Dr Michael Collins and Professor Steve Chadban
Clinical Project Manager:	Pushparaj Velayudham (AKTN)
Trial Number:	AKTN 15.02
Trial Registration Number:	ACTRN12617000358347
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:	Complete
Target Recruitment:	808 participants across Australia and New Zealand
Latest Output:	Balanced crystalloid solution versus saline in deceased donor kidney transplantation (BEST-Fluids): a pragmatic, double-blind, randomised, controlled trial

Research Team

A/Prof Michael Collins

Principal Investigator, Senior Staff Nephrologist, Royal Adelaide Hospital

Prof Steven Chadban

Principal Investigator, Senior Staff Nephrologist, Royal Prince Alfred Hospital

Background

Kidney failure is a significant, expensive health problem. Kidney transplantation improves survival, quality of life, and is much cheaper than dialysis treatment for kidney failure. 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 aimed to find out whether using a balanced low-chloride solution – Plasmalyte – as an alternative to normal saline in deceased donor kidney transplantation, would improve kidney transplant function, reduce the impact of DGF, and improve long-term outcomes for patients. Eight hundred and eight (808) participants were enrolled, randomised and followed up using ANZDATA, the Australia & New Zealand Dialysis & Transplant Registry.

Study Aims

BEST‑Fluids aimed to determine whether the use of a balanced, low-chloride intravenous fluid (Plasmalyte 148), compared with standard 0.9% saline, reduces the incidence of delayed graft function in adults and children receiving a deceased donor kidney transplant. The trial also assessed the impact of fluid choice on graft recovery, complications, quality of life, and overall cost-effectiveness.

Study Design and Population

Design:	Pragmatic, registry-embedded, multicentre, double-blind, randomised controlled trial
Setting:	16 kidney transplant centres across Australia and New Zealand
Randomisation:	Participants were randomly assigned (1:1) using an adaptive minimisation algorithm to intravenous balanced crystalloid solution (Plasma-Lyte 148) or saline during surgery and up until 48 hours after transplantation.
Participants:	808 adult and paediatric patients of any age receiving a kidney transplant from a deceased donor
Primary Outcome:	Incidence of delayed graft function (defined as dialysis within seven days of transplantation)
Secondary Outcomes:	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 Cost-effectiveness
Data Sources:	Outcomes collected using routine data through the Australia and New Zealand Dialysis and Transplant Registry (ANZDATA)