Baseline Characteristics and Representativeness of Participants in the BEST-Fluids Trial: A Randomized Trial of Balanced Crystalloid Solution Versus Saline in Deceased Donor Kidney Transplantation.

Delayed graft function (DGF) is a major complication of deceased donor kidney transplantation. Saline (0.9% sodium chloride) is a commonly used intravenous fluid in transplantation but may increase the risk of DGF because of its high chloride content. Better Evidence for Selecting Transplant Fluids (BEST-Fluids), a pragmatic, registry-based, double-blind, randomized trial, sought to determine whether using a balanced low-chloride crystalloid solution (Plasma-Lyte 148) instead of saline would reduce DGF. We sought to evaluate the generalizability of the trial cohort by reporting the baseline characteristics and representativeness of the trial participants in detail. We compared the characteristics of BEST-Fluids participants with those of a contemporary cohort of deceased donor kidney transplant recipients in Australia and New Zealand using data from the Australia and New Zealand Dialysis and Transplant Registry. To explore potential international differences, we compared trial participants with a cohort of transplant recipients in the United States using data from the Scientific Registry of Transplant Recipients. During the trial recruitment period, 2373 deceased donor kidney transplants were performed in Australia and New Zealand; 2178 were eligible' and 808 were enrolled in BEST-Fluids. Overall, trial participants and nonparticipants were similar at baseline. Trial participants had more coronary artery disease (standardized difference [d] = 0.09; BEST-Fluids participants had more comorbidities and received slightly fewer high-risk deceased donor kidneys but were otherwise representative of Australian and New Zealand transplant recipients and were generally similar to US recipients. The trial results should be broadly applicable to deceased donor kidney transplantation practice worldwide.

Informations de copyright

Copyright © 2022 The Author(s). Transplantation Direct. Published by Wolters Kluwer Health, Inc.

Déclaration de conflit d'intérêts

M.G.C. has received research support from Baxter Healthcare Pty Ltd, the manufacturer of Plasma-Lyte 148, through a Baxter Investigator-Initiated Research grant that provided fluids for the BEST-Fluids trial (commercial value of US $36 270). D.W.J. has received consultancy fees, research grants, speaker’s honoraria, and travel sponsorships from Baxter Healthcare and Fresenius Medical Care; consultancy fees from AstraZeneca and AWAK; speaker’s honoraria and travel sponsorships from ONO; and travel sponsorships from Amgen. D.R., L.E.H. L.A.V., E.M.P., C.K., and J.V. are employees of the sponsor, The University of Queensland. K.B.D.’s salary was funded by a BEAT-CKD grant‚ and she is an employee of the ANZDATA Registry. P.A.C. is the deputy executive officer of the ANZDATA Registry. C.M.H. has received fees for research committee activities from Janssen and GlaxoSmithKline paid to her institution; personal fees from Otsuka; research grants from Fresenius, Shire, and PKD Australia outside the submitted work; and research grants from Baxter and NHMRC related to the current project. L.W. works in the Department of Anaesthesia at Austin Health, which has received funding from Baxter Healthcare for investigator-initiated clinical research. L.W. has received honoraria from Baxter Healthcare for consulting activities. All L.W.’s fluid-related research, including study design, execution, data collection, analysis, and reporting, has been conducted independently of Baxter Healthcare and other commercial entities. Z.H.E. has received consultancy fees and travel sponsorships from AstraZeneca. W.H.L. has received honoraria from Alexion and education/research grants from Astellas. S.J.C. has received research support, travel support, speaker fees, or honoraria from AstraZeneca, Bayer, CSL-Behring, Novartis, and Takeda. The other authors declare no conflicts of interest.