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https://hdl.handle.net/2440/139751
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Type: | Journal article |
Title: | Balanced crystalloid solution versus saline in deceased donor kidney transplantation (BEST-Fluids): a pragmatic, double-blind, randomised, controlled trial |
Author: | Collins, M.G. Fahim, M.A. Pascoe, E.M. Hawley, C.M. Johnson, D.W. Varghese, J. Hickey, L.E. Clayton, P.A. Dansie, K.B. McConnochie, R.C. Vergara, L.A. Kiriwandeniya, C. Reidlinger, D. Mount, P.F. Weinberg, L. McArthur, C.J. Coates, P.T. Endre, Z.H. Goodman, D. Howard, K. et al. |
Citation: | The Lancet, 2023; 402(10396):105-117 |
Publisher: | Elsevier |
Issue Date: | 2023 |
ISSN: | 0140-6736 1474-547X |
Statement of Responsibility: | Michael G Collins ... Philip A Clayton ... P Toby Coates ... et al., on behalf of the BEST-Fluids Investigators‡ and the Australasian Kidney Trials Network |
Abstract: | BACKGROUND: Delayed graft function (DGF) is a major adverse complication of deceased donor kidney transplantation. Intravenous fluids are routinely given to patients receiving a transplant to maintain intravascular volume and optimise graft function. Saline (0·9% sodium chloride) is widely used but might increase the risk of DGF due to its high chloride content. We aimed to test our hypothesis that using a balanced low-chloride crystalloid solution (Plasma-Lyte 148) instead of saline would reduce the incidence of DGF. METHODS: BEST-Fluids was a pragmatic, registry-embedded, multicentre, double-blind, randomised, controlled trial at 16 hospitals in Australia and New Zealand. Adults and children of any age receiving a deceased donor kidney transplant were eligible; those receiving a multi-organ transplant or weighing less than 20 kg were excluded. 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 h after transplantation. Trial fluids were supplied in identical bags and clinicians determined the fluid volume, rate, and time of discontinuation. The primary outcome was DGF, defined as receiving dialysis within 7 days after transplantation. All participants who consented and received a transplant were included in the intention-to-treat analysis of the primary outcome. Safety was analysed in all randomly assigned eligible participants who commenced surgery and received trial fluids, whether or not they received a transplant. This study is registered with Australian New Zealand Clinical Trials Registry, (ACTRN12617000358347), and ClinicalTrials.gov (NCT03829488). FINDINGS: Between Jan 26, 2018, and Aug 10, 2020, 808 participants were randomly assigned to balanced crystalloid (n=404) or saline (n=404) and received a transplant (512 [63%] were male and 296 [37%] were female). One participant in the saline group withdrew before 7 days and was excluded, leaving 404 participants in the balanced crystalloid group and 403 in the saline group that were included in the primary analysis. DGF occurred in 121 (30%) of 404 participants in the balanced crystalloid group versus 160 (40%) of 403 in the saline group (adjusted relative risk 0·74 [95% CI 0·66 to 0·84; p<0·0001]; adjusted risk difference 10·1% [95% CI 3·5 to 16·6]). In the safety analysis, numbers of investigator-reported serious adverse events were similar in both groups, being reported in three (<1%) of 406 participants in the balanced crystalloid group versus five (1%) of 409 participants in the saline group (adjusted risk difference -0·5%, 95% CI -1·8 to 0·9; p=0·48). INTERPRETATION: Among patients receiving a deceased donor kidney transplant, intravenous fluid therapy with balanced crystalloid solution reduced the incidence of DGF compared with saline. Balanced crystalloid solution should be the standard-of-care intravenous fluid used in deceased donor kidney transplantation. |
Keywords: | BEST-Fluids Investigators Australasian Kidney Trials Network Humans Chlorides Kidney Transplantation Double-Blind Method Adult Child Australia Female Male Crystalloid Solutions |
Description: | Published Online June 18, 2023 |
Rights: | © 2023 Published by Elsevier Ltd. All rights reserved. |
DOI: | 10.1016/S0140-6736(23)00642-6 |
Published version: | http://dx.doi.org/10.1016/s0140-6736(23)00642-6 |
Appears in Collections: | Medicine publications |
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