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Statistical analysis plan for Better Evidence for Selecting Transplant Fluids (BEST-Fluids): a randomised controlled trial of the effect of intravenous fluid therapy with balanced crystalloid versus saline on the incidence of delayed graft function in deceased donor kidney transplantation

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dc.contributor.authorPascoe, E.M.
dc.contributor.authorChadban, S.J.
dc.contributor.authorFahim, M.A.
dc.contributor.authorHawley, C.M.
dc.contributor.authorJohnson, D.W.
dc.contributor.authorCollins, M.G.
dc.date.issued2022
dc.descriptionPublished online: 18 January 2022. Corrected by: Correction to: Statistical analysis plan for better evidence for selecting transplant fluids (BEST-fluids): a randomised controlled trial of the effect of intravenous fluid therapy with balanced crystalloid versus saline on the incidence of delayed graft function in deceased donor kidney transplantation (Trials, (2022), 23, 1, (52), 10.1186/s13063-021-05989-w), in Vol. 23, Issue 1, 123. Following the publication of the original article [1], we were notified that an incorrect additional file was published alongside the paper. The original article has been corrected.
dc.description.abstractBackground: Delayed graft function, or the requirement for dialysis due to poor kidney function, is a frequent complication of deceased donor kidney transplantation that is associated with inferior outcomes. Intravenous fluids with a high chloride content, such as isotonic sodium chloride (0.9% saline), are widely used in transplantation but may increase the risk of poor kidney function. The primary objective of the BEST-Fluids trial is to compare the effect of a balanced low-chloride crystalloid, Plasma-Lyte 148 (Plasmalyte), versus 0.9% saline on the incidence of DGF in deceased donor kidney transplant recipients. This article describes the statistical analysis plan for the trial. Methods and design: BEST-Fluids is an investigator-initiated, pragmatic, registry-based, multi-centre, double-blind, randomised controlled trial. Eight hundred patients (adults and children) in Australia and New Zealand with endstage kidney disease admitted for a deceased donor kidney transplant were randomised to intravenous fluid therapy with Plasmalyte or 0.9% saline in a 1:1 ratio using minimization. The primary outcome is delayed graft function (dialysis within seven days post-transplant), which will be modelled using a log-binomial generalised linear mixed model with fixed effects for treatment group, minimization variables, and ischaemic time and a random intercept for study centre. Secondary outcomes including early kidney transplant function (a ranked composite of dialysis duration and the rate of graft function recovery), treatment for hyperkalaemia, and graft survival and will be analysed using a similar modelling approach appropriate for the type of outcome.Discussion: BEST-Fluids will determine whether Plasmalyte reduces the incidence of DGF and has a beneficial effect on early kidney transplant outcomes relative to 0.9% saline and will inform clinical guidelines on intravenous fluids for deceased donor kidney transplantation. The statistical analysis plan describes the analyses to be undertaken and specified before completion of follow-up and locking the trial databases. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12617000358347. Prospectively registered on 8 March 2017 ClinicalTrials.gov identifier NCT03829488. Registered on 4 February 2019
dc.description.statementofresponsibilityElaine M. Pascoe, Steven J. Chadban, Magid A. Fahim, Carmel M. Hawley, David W. Johnson, Michael G. Collins and for the BEST-fluids Investigators and the Australasian Kidney Trials Network
dc.identifier.citationTrials, 2022; 23(1):52-1-52-4
dc.identifier.doi10.1186/s13063-021-05989-w
dc.identifier.issn1745-6215
dc.identifier.issn1745-6215
dc.identifier.orcidCollins, M.G. [0000-0003-2169-9087]
dc.identifier.urihttps://hdl.handle.net/2440/136683
dc.language.isoen
dc.publisherBioMed Central
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/1092957
dc.rights© The Author(s). 2022, corrected publication 2022. 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.
dc.source.urihttps://doi.org/10.1186/s13063-021-05989-w
dc.subjectBEST-fluids Investigators and the Australasian Kidney Trials Network
dc.subjectEnd-stage kidney disease; Delayed graft function; Kidney transplantation; Intravenous fluids; Plasma-Lyte 148; 0.9% saline; Randomised controlled trial; Statistical analysis plan
dc.subject.meshKidney
dc.subject.meshHumans
dc.subject.meshFluid Therapy
dc.subject.meshKidney Transplantation
dc.subject.meshIncidence
dc.subject.meshGraft Survival
dc.subject.meshAustralia
dc.subject.meshDelayed Graft Function
dc.subject.meshCrystalloid Solutions
dc.subject.meshSaline Solution
dc.titleStatistical analysis plan for Better Evidence for Selecting Transplant Fluids (BEST-Fluids): a randomised controlled trial of the effect of intravenous fluid therapy with balanced crystalloid versus saline on the incidence of delayed graft function in deceased donor kidney transplantation
dc.typeJournal article
pubs.publication-statusPublished

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