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

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Background: Delayed graft function (DGF), the need for post-transplant dialysis due to poor graft function, is a major complication of deceased donor kidney transplantation. Isotonic 0.9% sodium chloride (saline) is a widely used intravenous fluid in transplantation but may increase the risk of DGF due to its high chloride content. BEST-Fluids is a pragmatic, registry-based, double-blind randomized controlled trial to determine if using a balanced low-chloride crystalloid solution (Plasma-Lyte 148) instead of saline will reduce the incidence of DGF and improve other transplant outcomes. The aim of this presentation is to describe the baseline characteristics and representativeness of trial participants. Methods: Comparison of demographic and clinical characteristics between the BEST-Fluids participants and all other recipients of a deceased donor kidney transplant during the same period in Australia and New Zealand. Data were obtained from the Australia & New Zealand Dialysis & Transplant (ANZDATA) Registry. Results: From January 2018 to August 2020, 2178 deceased donor kidney transplants were performed; 808 of these (37%) enrolled in BEST-Fluids. The groups were similar in age, gender, BMI, smoking, kidney failure cause, graft number, dialysis modality, co-morbidities (diabetes, cerebrovascular and peripheral vascular disease), HLA mismatches, peak panel reactive antibody, donor age, cause of death, terminal creatinine, expanded criteria donor status and total ischemic time (p>0.05 for all comparisons). However, trial participants had more coronary artery disease (24% vs 20%, p=0.03), longer mean dialysis duration (41 vs 35 months, p<0.0001), and their donors were less likely to be hypertensive (22% vs 27%, p=0.01), be a circulatory death donor (25% vs 31%, p=0.002), or be in the highest Kidney Donor Risk Index tertile (30% vs 35%, p=0.02). Conclusions: BEST-Fluids trial participants had a slightly higher co-morbidity burden and received slightly fewer high risk deceased donor kidneys, but were otherwise representative of the wider transplant population. The trial results are likely to be applicable in a broad range of settings. Funding: Commercial Support - Baxter Healthcare Corporation, Government Support - Non-U.S.

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