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Abstract: FR-OR61

The BEST-Fluids Trial: A Randomized Controlled Trial of Balanced Crystalloid Solution vs. Saline to Prevent Delayed Graft Function in Deceased Donor Kidney Transplantation

Session Information

  • High-Impact Clinical Trials
    November 04, 2022 | Location: W415 Valencia, Orange County Convention Center‚ West Building
    Abstract Time: 10:30 AM - 10:45 AM

Category: Transplantation

  • 2002 Transplantation: Clinical

Authors

  • Collins, Michael G., Royal Adelaide Hospital, Adelaide, South Australia, Australia
  • Fahim, Magid, The University of Queensland, Brisbane, Queensland, Australia
  • Pascoe, Elaine, The University of Queensland, Brisbane, Queensland, Australia
  • Hawley, Carmel, The University of Queensland, Brisbane, Queensland, Australia
  • Johnson, David W., The University of Queensland, Brisbane, Queensland, Australia
  • Clayton, Philip A., Australia and New Zealand Dialysis and Transplant Registry, Adelaide, South Australia, Australia
  • Chadban, Steven J., Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Group or Team Name

  • The BEST-Fluids Investigators
Background

Delayed graft function (DGF) is a frequent complication of deceased donor kidney transplantation and is associated with inferior outcomes. Saline (0.9% sodium chloride) is the most widely used intravenous (IV) fluid in transplantation but may increase the risk of DGF due to its high chloride content. We hypothesized that using a balanced low-chloride crystalloid solution (Plasma-Lyte 148) instead of saline would reduce the incidence of DGF.

Methods

BEST-Fluids was an investigator-initiated, pragmatic, registry-based, multicenter, double-blind, randomized controlled trial (NCT03829488). Deceased donor kidney transplant recipients were randomized 1:1 to IV fluid therapy with balanced crystalloid solution or saline during surgery and for up to 48 hours post-transplant until fluids were ceased. The primary outcome was DGF, defined as dialysis within seven days of transplant. Secondary outcomes included post-transplant hyperkalemia (potassium ≥5.5 mmol/L), and graft function (eGFR), acute rejection, graft failure (censored for death) and mortality to 52 weeks.

Results

In total, 808 participants (median age 55 years, 37% female, 41% non-white) were randomized and received a transplant; 807 (99.9%) were included in the primary analysis (404 balanced crystalloid, 403 saline). Participants in the balanced crystalloid group had a lower incidence of DGF compared with the saline group (30.0% vs 39.7%; adjusted relative risk [RR] 0.75, 95% CI 0.66–0.84, P<0.0001). The effect was consistent across pre-specified subgroups of donor type, kidney donor risk index, machine perfusion and ischemic time (RR 0.65 to 0.88). The incidence of hyperkalemia (56.4% vs 56.6%, RR 1.00, 95% CI 0.90–1.12) was the same in both groups. There were no significant differences in graft function at 52 weeks (54.0±20.4 vs 54.8±21.6 mL/min/1.73m2; adjusted mean difference -0.87, 95% CI -2.93–1.19), acute rejection (RR 1.28, 95% CI 0.94–1.76), graft failure (hazard ratio [HR] 0.72, 95% CI 0.48–1.10) or mortality (HR 1.06, 95% CI 0.39 to 2.85). Numbers of serious adverse events were similar in both groups.

Conclusion

In deceased donor kidney transplant recipients, IV fluid therapy with balanced crystalloid solution reduced the incidence of DGF compared with saline.

Funding

  • Commercial Support