Please use this identifier to cite or link to this item: https://hdl.handle.net/2440/126091
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Type: Journal article
Title: 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
Author: Collins, M.G.
Fahim, M.A.
Pascoe, E.M.
Dansie, K.B.
Hawley, C.M.
Clayton, P.A.
Howard, K.
Johnson, D.W.
McArthur, C.J.
McConnochie, R.C.
Mount, P.F.
Reidlinger, D.
Robison, L.
Varghese, J.
Vergara, L.A.
Weinberg, L.
Chadban, S.J.
BEST-Fluids Investigators and the Australasian Kidney Trials Network
Citation: Trials, 2020; 21(1):428-1-428-19
Publisher: BMC Springer Nature
Issue Date: 2020
ISSN: 1745-6215
1745-6215
Statement of
Responsibility: 
Michael G. Collins, Magid A. Fahim, Elaine M. Pascoe, Kathryn B. Dansie, Carmel M. Hawley, Philip A. Clayton, Kirsten Howard, David W. Johnson, Colin J. McArthur, Rachael C. McConnochie, Peter F. Mount, Donna Reidlinger, Laura Robison, Julie Varghese, Liza A. Vergara, Laurence Weinberg, Steven J. Chadban, and for the BEST-Fluids Investigators and the Australasian Kidney Trials Network
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.
Keywords: Balanced crystalloid
Delayed graft function
End-stage kidney disease
Intravenous fluids
Kidney transplantation
Normal saline
Peri-operative care
Plasma-Lyte 148
Pragmatic trial
Registry trial
Rights: Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
DOI: 10.1186/s13063-020-04359-2
Grant ID: http://purl.org/au-research/grants/nhmrc/1092957
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