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.
Abstract | BACKGROUND: METHODS: BEST-Fluids is an investigator-initiated, pragmatic, registry-based, multi-center, double-blind, randomized controlled trial. The primary objective is to compare the effect of intravenous Plasma-Lyte 148 ( Plasmalyte), a balanced, low- chloride solution, with the effect of 0.9% saline on the incidence of delayed graft function in deceased donor kidney transplant recipients. From January 2018 onwards, 800 participants admitted for deceased donor kidney transplantation will be recruited over 3 years in Australia and New Zealand. Participants are randomized 1:1 to either intravenous Plasmalyte or 0.9% saline peri-operatively and until 48 h post-transplant, or until fluid is no longer required; whichever comes first. Follow up is for 1 year. The primary outcome is the incidence of delayed graft function, defined as dialysis in the first 7 days post-transplant. Secondary outcomes include early kidney transplant function (composite of dialysis duration and rate of improvement in graft function when dialysis is not required), hyperkalemia, mortality, graft survival, graft function, quality of life, healthcare resource use, and cost-effectiveness. Participants are enrolled, randomized, and followed up using the Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry. DISCUSSION: TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12617000358347. Registered on 8 March 2017. ClinicalTrials.gov: NCT03829488. Registered on 4 February 2019.
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Authors | Michael G Collins, Magid A Fahim, Elaine M Pascoe, Kathryn B Dansie, Carmel M Hawley, Philip A Clayton, Kirsten Howard, David W Johnson, Colin J McArthur, Rachael C McConnochie, Peter F Mount, Donna Reidlinger, Laura Robison, Julie Varghese, Liza A Vergara, Laurence Weinberg, Steven J Chadban, BEST-Fluids Investigators and the Australasian Kidney Trials Network |
Journal | Trials
(Trials)
Vol. 21
Issue 1
Pg. 428
(May 25 2020)
ISSN: 1745-6215 [Electronic] England |
PMID | 32450917
(Publication Type: Clinical Trial Protocol, Journal Article)
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Chemical References |
- Gluconates
- Plasma-lyte 148
- Saline Solution
- Magnesium Chloride
- Sodium Chloride
- Sodium Acetate
- Potassium Chloride
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Topics |
- Administration, Intravenous
- Australia
- Clinical Trials, Phase III as Topic
- Delayed Graft Function
(epidemiology, etiology)
- Double-Blind Method
- Fluid Therapy
(methods)
- Gluconates
(pharmacology)
- Graft Survival
- Humans
- Kidney Transplantation
(adverse effects)
- Magnesium Chloride
(pharmacology)
- Multicenter Studies as Topic
- Perioperative Care
(methods)
- Postoperative Complications
(epidemiology)
- Potassium Chloride
(pharmacology)
- Pragmatic Clinical Trials as Topic
- Quality of Life
- Registries
- Saline Solution
(pharmacology)
- Sodium Acetate
(pharmacology)
- Sodium Chloride
(pharmacology)
- Tissue Donors
- Treatment Outcome
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