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

Autor: Peter F Mount, Elaine M. Pascoe, Kathryn Dansie, Rachael C. McConnochie, Colin McArthur, Laura Robison, Philip A. Clayton, Julie M. Varghese, David W. Johnson, Liza A. Vergara, Kirsten Howard, Donna Reidlinger, Laurence Weinberg, Carmel M. Hawley, Michael G. Collins, Magid Fahim, Steven J. Chadban
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Sodium Acetate
Hyperkalemia
medicine.medical_treatment
Medicine (miscellaneous)
Sodium Chloride
030204 cardiovascular system & hematology
Pragmatic trial
Potassium Chloride
law.invention
Kidney transplantation
Study Protocol
Postoperative Complications
0302 clinical medicine
Randomized controlled trial
law
Multicenter Studies as Topic
Pharmacology (medical)
Registries
030212 general & internal medicine
Saline
lcsh:R5-920
Graft Survival
Acute kidney injury
End-stage kidney disease
Tissue Donors
Treatment Outcome
surgical procedures
operative
Administration
Intravenous
Saline Solution
medicine.symptom
lcsh:Medicine (General)
Balanced crystalloid
medicine.medical_specialty
Magnesium Chloride
Renal function
Gluconates
Perioperative Care
03 medical and health sciences
Double-Blind Method
Pragmatic Clinical Trials as Topic
medicine
Humans
Normal saline
Dialysis
business.industry
Australia
Plasma-Lyte 148
Delayed graft function
Intravenous fluids
medicine.disease
Peri-operative care
Surgery
Transplantation
Clinical Trials
Phase III as Topic
Quality of Life
Fluid Therapy
Registry trial
business
Zdroj: Trials, Vol 21, Iss 1, Pp 1-19 (2020)
Trials
ISSN: 1745-6215
DOI: 10.1186/s13063-020-04359-2
Popis: Background Delayed graft function, the requirement for dialysis due to poor kidney function post-transplant, is a frequent complication of deceased donor kidney transplantation and is associated with inferior outcomes and higher costs. Intravenous fluids given during and after transplantation may affect the risk of poor kidney function after transplant. The most commonly used fluid, isotonic sodium chloride (0.9% saline), contains a high chloride concentration, which may be associated with acute kidney injury, and could increase the risk of delayed graft function. Whether using a balanced, low-chloride fluid instead of 0.9% saline is safe and improves kidney function after deceased donor kidney transplantation is unknown. 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 If using Plasmalyte instead of 0.9% saline is effective at reducing delayed graft function and improves other clinical outcomes in deceased donor kidney transplantation, this simple, inexpensive change to using a balanced low-chloride intravenous fluid at the time of transplantation could be easily implemented in the vast majority of transplant settings worldwide. Trial registration Australian New Zealand Clinical Trials Registry: ACTRN12617000358347. Registered on 8 March 2017. ClinicalTrials.gov: NCT03829488. Registered on 4 February 2019.
Databáze: OpenAIRE
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