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

Michael G Collins; Magid A Fahim; Elaine M Pascoe; Carmel M Hawley; David W Johnson; Julie Varghese; Laura E Hickey; Philip A Clayton; John S Gill; Kathryn B Dansie; Rachael C McConnochie; Liza A Vergara; Charani Kiriwandeniya; Donna Reidlinger; Peter F Mount; Laurence Weinberg; Colin J McArthur; P Toby Coates; Zoltan H Endre; David Goodman; Kirsten Howard; Martin Howell; Jagadish S Jamboti; John Kanellis; Jerome M Laurence; Wai H Lim; Steven J McTaggart; Philip J O'Connell; Helen L Pilmore; Germaine Wong; Steven J Chadban

doi:10.1097/TXD.0000000000001399

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

Transplant Direct. 2022 Nov 4;8(12):e1399. doi: 10.1097/TXD.0000000000001399. eCollection 2022 Dec.

Authors

Michael G Collins^{1

2

3

4}, Magid A Fahim^{4

5}, Elaine M Pascoe⁴, Carmel M Hawley^{4

5

6}, David W Johnson^{4

5

6}, Julie Varghese⁴, Laura E Hickey⁴, Philip A Clayton^{1

3

7}, John S Gill⁸, Kathryn B Dansie^{3

7}, Rachael C McConnochie⁹, Liza A Vergara⁴, Charani Kiriwandeniya⁴, Donna Reidlinger⁴, Peter F Mount^{10

11}, Laurence Weinberg^{12

13}, Colin J McArthur⁹, P Toby Coates^{1

3}, Zoltan H Endre^{14

15}, David Goodman¹⁶, Kirsten Howard^{17

18}, Martin Howell^{17

18}, Jagadish S Jamboti^{19

20}, John Kanellis^{21

22}, Jerome M Laurence²³, Wai H Lim^{20

24}, Steven J McTaggart²⁵, Philip J O'Connell^{26

27}, Helen L Pilmore^{2

28}, Germaine Wong^{17

26

27}, Steven J Chadban^{29

30}

Affiliations

¹ Central Northern Adelaide Renal and Transplantation Service, Royal Adelaide Hospital, Adelaide, Australia.
² Department of Renal Medicine, Auckland City Hospital, Auckland, New Zealand.
³ Faculty of Medical and Health Sciences, The University of Adelaide, Adelaide, Australia.
⁴ Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia.
⁵ Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia.
⁶ Translational Research Institute, Brisbane, Queensland, Australia.
⁷ Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry, South Australian Health and Medical Research Institute (SAHMRI), Adelaide, Australia.
⁸ Division of Nephrology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
⁹ Department of Critical Care Medicine, Auckland City Hospital, Auckland, New Zealand.
¹⁰ Department of Nephrology, Austin Health, Melbourne, Australia.
¹¹ Department of Medicine (Austin), The University of Melbourne, Parkville, Melbourne, Australia.
¹² Department of Anaesthesia, Austin Health, Melbourne, Australia.
¹³ The University of Melbourne, Department of Critical Care, Melbourne, Australia.
¹⁴ Department of Nephrology, Prince of Wales Hospital, Randwick, Sydney, Australia.
¹⁵ Prince of Wales Clinical School, University of New South Wales, Sydney, Australia.
¹⁶ Department of Nephrology, St. Vincent's Hospital, Melbourne, Australia.
¹⁷ School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.
¹⁸ Menzies Centre for Health Policy and Economics, University of Sydney, Sydney, Australia.
¹⁹ Department of Nephrology and Renal Transplantation, Fiona Stanley Hospital, Murdoch, WA, Australia.
²⁰ School of Medicine, University of Western Australia, Perth, WA, Australia.
²¹ Department of Nephrology, Monash Health, Clayton, Victoria, Australia.
²² Centre for Inflammatory Diseases, Department of Medicine, Monash University, Clayton, Victoria, Australia.
²³ Institute of Academic Surgery, Royal Prince Alfred Hospital, University of Sydney, Sydney, NSW, Australia.
²⁴ Department of Renal Medicine, Sir Charles Gairdner Hospital, Perth, WA, Australia.
²⁵ Child and Adolescent Renal Service, Queensland Children's Hospital, Brisbane, QLD, Australia.
²⁶ Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney, NSW, Australia.
²⁷ Department of Renal and Transplantation Medicine, Westmead Hospital, NSW, Australia.
²⁸ Department of Medicine, University of Auckland, Auckland, New Zealand.
²⁹ Department of Renal Medicine, Kidney Centre, Royal Prince Alfred Hospital, Sydney, Australia.
³⁰ Kidney Node, Charles Perkins Centre, The University of Sydney, Sydney, Australia.

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.