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

Collins, Michael G.; Fahim, Magid; Pascoe, Elaine M.; Dansie, Kathryn; Hawley, Carmel; Clayton, Philip; Howard, Kirsten; Johnson, David W.; McArthur, Colin; McConnochie, Rachael; Mount, Peter F.; Reidlinger, Donna; Robison, Laura; Varghese, Julie; Vergara, Liza A.; Weinberg, Laurence; Chadban, Steven J.

doi:10.1186/s13063-020-04359-2

Cited by 18 publications

(18 citation statements)

References 47 publications

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“…The primary objective is to compare the effect of Plasmalyte with the effect of 0.9% saline on the incidence of DGF in deceased donor kidney transplant recipients. The secondary objectives are to determine whether perioperative IV therapy using Plasmalyte, compared with 0.9% saline, [ 1 ] improves the recovery of graft function in the first week after transplantation, [ 2 ] reduces the number of dialysis treatments required, and the duration of dialysis dependence after transplantation, [ 3 ] reduces the incidence and severity of hyperkalemia, [ 4 ] improves graft survival and death-censored graft survival at 12 months, [ 5 ] improves graft function up to 12 months post-transplant, [ 6 ] improves health-related quality of life, [ 7 ] reduces hospital length of stay and health-related costs, and [ 8 ] is cost-effective [ 16 ].…”

Section: Introductionmentioning

confidence: 99%

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

Pascoe

Chadban

Fahim

et al. 2022

Trials

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Background 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 end-stage 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

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Section: Introductionmentioning

confidence: 99%

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

Pascoe

Chadban

Fahim

et al. 2022

Trials

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“…For example, by facilitating the inclusion of a relatively large group of patients and embedding the research question in the clinical practice (ie, the registry). 31 , 32 …”

Section: Resultsmentioning

confidence: 99%

Alternative Randomized Trial Designs in Surgery

et al. 2022

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Introduction: Randomized controlled trials (RCTs) yield the highest level of evidence but are notoriously difficult to perform in surgery. Surgical RCTs may be hampered by slow accrual, the surgical learning curve, and lack of financial support. Alternative RCT designs such as stepped-wedge randomized controlled trials (SW-RCTs), registry-based randomized controlled trials (RB-RCTs), and trials-within-cohorts (TwiCs) may overcome several of these difficulties. This review provides an overview of alternative RCT designs used in surgical research. Methods: We systematically searched PubMed, EMBASE, and Cochrane Central for surgical SW-RCTs, RB-RCTs, and TwiCs. A surgical RCT was defined as a randomized trial that studied interventions in patients undergoing general surgery, regardless of the affiliation of the corresponding author. Exponential regression analysis was performed to assess time trends. Results: Overall, 41 surgical RCTs using alternative designs were identified, including 17 published final RCT reports and 24 published protocols of ongoing RCTs. These included 25 SW-RCTs (61%), 13 RB-RCTs (32%), and 3 TwiCs (7%). Most of these RCTs were performed in Europe (63%) and within gastrointestinal/oncological surgery (41%). The total number of RCTs using alternative designs exponentially increased over the last 7 years (P<0.01), with 95% (n=39/41) of the total number published within this time frame. The most reported reasons for using alternative RCT designs were avoidance of contamination for SW-RCTs and generalizability of the trial population for RB-RCTs and TwiCs. Conclusions: Alternative RCT designs are increasingly used in surgical research, mostly in Europe and within gastrointestinal/oncological surgery. When adequately used, these alternative designs may overcome several difficulties associated with surgical RCTs.

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“… 11 An ongoing trial in this area is Better Evidence for Selecting Transplant Fluids, which also compares the effects of Plasma-Lyte 148 versus 0.9% saline on delayed graft function in 800 deceased donor kidney transplants. 12 It is humbling that almost 200 years after intravenous fluids were invented, we are still struggling to answer fundamental questions regarding their makeup and use. From the evidence so far, outside select settings such as hyperchloremia or traumatic brain injury, the choice of intravenous fluids does not seem to matter.…”

Section: The Basics Trialmentioning

confidence: 99%