Dataset Information

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.

ABSTRACT: 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.

Methods

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.

Results

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; P = 0.03), longer dialysis duration (d = 0.18, P < 0.001), and fewer hypertensive (d = -0.11, P = 0.03) and circulatory death (d = -0.14, P < 0.01) donors than nonparticipants. Most key characteristics were similar between trial participants and US recipients, with moderate differences (|d| ≥ 0.2; all P < 0.001) in kidney failure cause, diabetes, dialysis duration, ischemic time, and several donor risk predictors, likely reflecting underlying population differences.

Conclusions

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.

SUBMITTER: Collins MG

PROVIDER: S-EPMC9722559 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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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.

Collins Michael G MG Fahim Magid A MA Pascoe Elaine M EM Hawley Carmel M CM Johnson David W DW Varghese Julie J Hickey Laura E LE Clayton Philip A PA Gill John S JS Dansie Kathryn B KB McConnochie Rachael C RC Vergara Liza A LA Kiriwandeniya Charani C Reidlinger Donna D Mount Peter F PF Weinberg Laurence L McArthur Colin J CJ Coates P Toby PT Endre Zoltan H ZH Goodman David D Howard Kirsten K Howell Martin M Jamboti Jagadish S JS Kanellis John J Laurence Jerome M JM Lim Wai H WH McTaggart Steven J SJ O'Connell Philip J PJ Pilmore Helen L HL Wong Germaine G Chadban Steven J SJ

Transplantation direct 20221104 12

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 red ...[more]

PMID: 36479278

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Project description:BackgroundDelayed 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 designBEST-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.DiscussionBEST-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 registrationAustralian New Zealand Clinical Trials Registry ACTRN12617000358347 . Prospectively registered on 8 March 2017 ClinicalTrials.gov identifier NCT03829488 . Registered on 4 February 2019.

Project description:BackgroundIntravenous fluid therapy is important for pediatric and adult patients in intensive care units (ICUs). However, medical professionals continue to struggle to determine the most appropriate fluids to obtain the best possible outcomes for each patient.ObjectiveWe conducted a meta-analysis involving cohort studies and randomized controlled trials (RCTs) to compare the influence of balanced crystalloid solutions and normal saline among patients in ICUs.Patients and methodsStudies that compared balanced crystalloid solutions and saline in ICU patients from databases including PubMed, Embase, Web of Science, and Cochrane Library were systematically searched up to July 25, 2022. The primary outcomes were mortality and renal-related outcomes, which included major adverse kidney events within 30 days (MAKE30), acute kidney injury (AKI), new receipt of renal replacement therapy (RRT), maximum creatinine increasing, maximum creatinine level, and final creatinine level ≥ 200% of baseline. Service utilization including length of hospital stay, ICU stay, ICU-free days and ventilator-free days were also reported.ResultsA total of 13 studies (10 RCTs and 3 cohort studies) involving 38,798 patients in ICUs met the selection criteria. Our analysis revealed that each subgroup had no significant difference in mortality outcomes among ICU patients between balanced crystalloid solutions and normal saline. A significant difference was detected between the adult groups (odds ratio [OR], 0.92; 95% confidence interval [CI], [0.86, 1.00]; p = 0.04) indicating that the AKI in the balanced crystalloid solutions group was lower than that in the normal saline group. Other renal-related outcomes, such as MAKE30, RRT, maximum creatinine increasing, maximum creatinine level, and final creatinine level ≥ 200% of baseline showed no significant difference between the two groups. Regarding secondary outcomes, the balanced crystalloid solution group had a longer ICU stay time (WMD, 0.02; 95% CI, [0.01, 0.03]; p = 0.0004 and I2 = 0%; p = 0.96) than the normal saline group among adult patients. Furthermore, children treated with balanced crystalloid solution had a shorter hospital stay time (WMD, - 1.10; 95% CI, [- 2.10, - 0.10]; p = 0.03 and I2 = 17%; p = 0.30) than those treated with saline.ConclusionsCompared with saline, balanced crystalloid solutions could not reduce the risk of mortality and renal-related outcomes, including MAKE30, RRT, maximum creatinine increasing, maximum creatinine level, and final creatinine level ≥ 200% of baseline, but the solutions may reduce total AKI incidence among adult patients in ICUs. For service utilization outcomes, balanced crystalloid solutions were associated with a longer length of ICU stay in the adult group and shorter length of hospital stay in the pediatric group.

Project description:BackgroundFluid resuscitation is a cornerstone of septic shock management in pediatric patients, with normal saline (NS) being the traditional choice. However, balanced solutions (BS) have gained attention due to their potential to mitigate acid-base and electrolyte disturbances. Despite this, the optimal choice between BS and NS for pediatric sepsis remains unclear. Therefore, we aimed to conduct a meta-analysis comparing the clinical outcomes of BS versus NS in pediatric patients with sepsis.MethodsWe systematically searched PubMed, EMBASE, and Cochrane Central Register of Controlled Trials, along with reference lists of retrieved publications, for studies comparing clinical outcomes in pediatric patients with sepsis treated with BS versus NS. Our outcomes of interest included acute kidney injury (AKI), hospital mortality, hospital length of stay, pediatric intensive care unit (PICU) length of stay, need for renal replacement therapy, hyperchloremia and mechanical ventilation. We performed statistical analysis using Review Manager Web 8.0.0 and Rstudio.ResultsWe included 12,231 patients from 8 studies, of which 4 were randomized clinical trials (RCTs). BS was used to treat septic shock in 2,460 (20.1%) patients. The mean age was 5.98 ± 3.08 years, with 43.82% female patients. Follow-up ranged from 3 to 90 days. We found no statistically significant difference between groups in AKI, hospital mortality, mechanical ventilation, need for renal replacement therapy, and PICU length of stay. Hospital length of stay in days was significantly longer with BS compared to NS (MD 3.38; 95% CI 1.13 to 5.64; p = 0.003; I² = 0%) and the occurrence of hyperchloremia was lower in the BS compared to NS (RR 0.70; 95% CI 0.59 to 0.82; p = 0.0001; I² = 0%). In a subgroup analysis of RCTs only, AKI occurrence was not significantly different between BS and NS groups (RR 0.81; 95% CI 0.48 to 1.38; p = 0.44; I² = 18%). However, the need for renal replacement therapy was significantly less frequent in patients treated with BS compared to NS (RR 0.58; 95% CI 0.39 to 0.87; p = 0.008; I² = 0%).ConclusionIn pediatric septic shock patients, treatment with balanced solutions (BS) was associated with a lower need for renal replacement therapy and a reduced occurrence of hyperchloremia. However, hospital length of stay was longer in patients treated with BS compared to those receiving normal saline (NS). These results underscore the complexity of fluid management in pediatric septic shock and emphasize the need for further research.

Dataset Information

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.

Methods

Results

Conclusions

Publications

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.

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