Better Evidence for Selecting Transplant Fluids
BEST-Fluids
An Investigator-initiated, Pragmatic, Registry-based, Multi-centre, Double-blind, Randomised Controlled Trial Evaluating the Effect of Plasmalyte Versus 0.9% Saline on Early Kidney Transplant Function in Deceased Donor Kidney Transplantation
2 other identifiers
interventional
808
2 countries
18
Brief Summary
End-stage kidney disease (ESKD) is a significant, expensive health problem. Kidney transplantation improves survival, quality of life, and is much cheaper than dialysis treatment for ESKD. However sometimes kidney transplants from a deceased donor function poorly after surgery, and a period of continued dialysis is needed, a condition known as delayed graft function (DGF). In addition to complicating recovery, DGF can adversely affect long-term kidney function and the health of the recipient. Intravenous fluids given during and after transplantation (usually 0.9% sodium chloride or saline) are critical to preserve kidney transplant function, but there is evidence that 0.9% saline may not be the safest fluid to use due to its high chloride content. BEST Fluids is a randomised controlled trial that aims to find out whether using a balanced low-chloride solution - Plasma-Lyte 148® - as an alternative to normal saline in deceased donor kidney transplantation, will improve kidney transplant function, reduce the impact of DGF, and improve long-term outcomes for patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2018
Typical duration for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 26, 2018
CompletedFirst Submitted
Initial submission to the registry
January 21, 2019
CompletedFirst Posted
Study publicly available on registry
February 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 3, 2022
CompletedOctober 15, 2024
September 1, 2021
3.5 years
January 21, 2019
October 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
The proportion of participants with Delayed Graft Function
Delayed Graft Function defined as receiving treatment with any form of dialysis in the first seven days after transplant
7 Days
Secondary Outcomes (21)
Early Kidney Transplant Function
a. Duration of Delayed Graft Function - 12 Weeks; b. Rate of recovery of kidney transplant graft function - 2 Days
Number of dialysis sessions
First 28 days post-transplant
Total duration of dialysis
12 Weeks
Creatinine reduction ratio from day 1 to day 2 post-transplant
Day 1 to Day 2 post-transplant
Reduction in serum creatinine of greater than or equal to 10%
First 7 days post-transplant
- +16 more secondary outcomes
Study Arms (2)
Plasma-Lyte 148 (approx. pH 7.4) IV Infusion
EXPERIMENTALPlasma-Lyte 148 (approx. pH 7.4) IV Infusion intravenous fluid therapy will be used for all maintenance, replacement and resuscitation purposes from randomization onwards until 48 hours post-transplant, or until fluid therapy is no longer required, if earlier.
0.9% SODIUM CHLORIDE 9g/L injection BP
ACTIVE COMPARATOR0.9% saline intravenous fluid therapy will be used for all maintenance, replacement and resuscitation purposes from randomization onwards until 48 hours post-transplant, or until fluid therapy is no longer required, if earlier.
Interventions
Plasma-Lyte 148 (approx. pH 7.4) IV Infusion is a sterile, clear, non-pyrogenic isotonic solution and when administered intravenously is a source of water, electrolytes and calories. Plasma-Lyte 148 intravenous infusion is indicated as a source of water \& electrolytes or as an alkalinising agent.
Sodium chloride (0.9% saline) infusion is a sterile, non-pyrogenic solution of sodium chloride in Water for Injections. The concentration of sodium chloride is 154mmol/L. Sodium chloride (0.9%) intravenous infusion is indicated for extra-cellular fluid replacement and in the management of metabolic alkalosis in the presence of fluid loss, and for restoring or maintaining the concentration of sodium and chloride ions.
Eligibility Criteria
You may qualify if:
- Adult or child with End-Stage Kidney Disease, of any cause, on maintenance dialysis, or who has pre-dialysis stage 5 chronic kidney disease with an estimated Glomerular Filtration Rate of \<15 mL/min/1.73m2, AND
- Planned deceased donor kidney transplant from a brain-death (DBD) or circulatory-death (DCD) organ donor within 24 hours, AND
- Written informed consent, or consent given by their parent or guardian (if age \<18), or other authorised person
You may not qualify if:
- Planned live donor kidney transplant (except where this is cancelled in favour or transplantation from a deceased donor)
- Planned multi-organ transplant (dual or en-bloc kidney transplants are not excluded)
- Children of weight \<20 kg, or a child that the treating physician believes should not be included in a study of blinded fluids due to their small body size
- Known hypersensitivity to the trial fluid preparations or packaging
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Queenslandlead
- Australian Government Department of Health and Ageingcollaborator
- Health Research Council, New Zealandcollaborator
- Baxter Healthcare Corporationcollaborator
Study Sites (18)
Sydney Children's Hospital
Randwick, New South Wales, 2031, Australia
Prince of Wales Hospital
Sydney, New South Wales, 2031, Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050, Australia
The Children's Hospital at Westmead
Sydney, New South Wales, 2145, Australia
Westmead Hospital
Sydney, New South Wales, 2145, Australia
Queensland Children's Hospital
Brisbane, Queensland, 4101, Australia
Princess Alexandra Hospital
Brisbane, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
St Vincent's Hospital (Melbourne) Ltd
Melbourne, Victoria, 3065, Australia
Austin Health
Melbourne, Victoria, 3084, Australia
Monash Children's Hospital
Melbourne, Victoria, 3168, Australia
Monash Medical Centre
Melbourne, Victoria, 3168, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009, Australia
Auckland City Hospital
Auckland, 1142, New Zealand
Starship Children's Hospital
Auckland, 1142, New Zealand
Christchurch Hospital
Christchurch, 8011, New Zealand
Wellington Hospital
Wellington, 6021, New Zealand
Related Publications (3)
Collins MG, Fahim MA, Pascoe EM, Hawley CM, Johnson DW, Varghese J, Hickey LE, Clayton PA, Dansie KB, McConnochie RC, Vergara LA, Kiriwandeniya C, Reidlinger D, Mount PF, Weinberg L, McArthur CJ, Coates PT, Endre ZH, Goodman D, Howard K, Howell M, Jamboti JS, Kanellis J, Laurence JM, Lim WH, McTaggart SJ, O'Connell PJ, Pilmore HL, Wong G, Chadban SJ; BEST-Fluids Investigators; Australasian Kidney Trials Network. Balanced crystalloid solution versus saline in deceased donor kidney transplantation (BEST-Fluids): a pragmatic, double-blind, randomised, controlled trial. Lancet. 2023 Jul 8;402(10396):105-117. doi: 10.1016/S0140-6736(23)00642-6. Epub 2023 Jun 18.
PMID: 37343576DERIVEDPascoe EM, Chadban SJ, Fahim MA, Hawley CM, Johnson DW, Collins MG; BEST-fluids Investigators and the Australasian Kidney Trials Network. 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. Trials. 2022 Jan 18;23(1):52. doi: 10.1186/s13063-021-05989-w.
PMID: 35042554DERIVEDCollins MG, Fahim MA, Pascoe EM, Dansie KB, Hawley CM, Clayton PA, Howard K, Johnson DW, McArthur CJ, McConnochie RC, Mount PF, Reidlinger D, Robison L, Varghese J, Vergara LA, Weinberg L, Chadban SJ; BEST-Fluids Investigators and the Australasian Kidney Trials Network. 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. Trials. 2020 May 25;21(1):428. doi: 10.1186/s13063-020-04359-2.
PMID: 32450917DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael Collins, MBChB,FRACP,PhD
Auckland District Health Board & The University of Auckland
- PRINCIPAL INVESTIGATOR
Steven Chadban, BMed(hons),FRACP,PhD
Sydney Local Health District & The University of Sydney
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2019
First Posted
February 4, 2019
Study Start
January 26, 2018
Primary Completion
July 29, 2021
Study Completion
May 3, 2022
Last Updated
October 15, 2024
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 2 years and ending 5 years following main publication. Proposals may be submitted up to 5 years following article publication. After 5 years, the data will be available in our University's data warehouse but without investigator support other than deposited metadata.
- Access Criteria
- An independent review board will assess proposals based on the following criteria: sound science, benefit-risk balancing and research team expertise.
Yes Individual participant data that underlie the results reported in the primary publication, after de-identification (text, tables, figures and appendices) will be available for individual participant data meta-analysis.