CompletedPhase 3ACTRN12617000358347

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.


Sponsor

Australasian Kidney Trials Network (University of Qld)

Enrollment

800 participants

Start Date

Jan 30, 2018

Study Type

Interventional

Conditions

Summary

Delayed or slow graft function (DGF), i.e. the requirement for dialysis, or poor kidney transplant graft function early after transplantation, affects 20-50% of deceased donor kidney transplants, and increases the risk of graft failure and mortality. DGF reflects acute kidney injury caused by ischaemia-reperfusion injury during transplantation, and is driven by donor, recipient and transplant factors. Intravenous fluids are a critical, albeit inexpensive, aspect of care that impacts early transplant function. Currently, isotonic sodium chloride (‘normal’ or 0.9% saline) is standard of care at the majority of transplant centres. However, 0.9% saline may be harmful due to its high chloride content relative to plasma, which causes metabolic acidosis and may promote acute kidney injury, and thus DGF. Studies of low-chloride balanced solutions versus normal saline in transplantation have shown reduced acidosis, but have been too small to show differences in transplant outcomes. The BEST-Fluids study (Better Evidence for Selecting Transplant Fluids) is a clinical trial investigating the difference between two standard practice fluids (Plasmalyte and normal saline) used before, during and after surgery in improving the lives of people who have a kidney transplant. The primary outcome investigates the requirement of dialysis in participants with delayed graft function (proportion of participants who require dialysis within first seven days) . Secondary outcomes include graft function, survival, and cost-effectiveness. This trial will show if Plasmalyte is better to normal saline in kidney transplantation, may result in cost savings and will rapidly translate into clinical practice.


Eligibility

Sex: Both males and females

Inclusion Criteria3

  • Adult or child with ESKD, of any cause, on maintenance dialysis, or who has chronic kidney disease with an estimated glomerular filtration rate of <15 mL/min/1.73m2 (as determined by the CKD-EPI equation for adults or the bedside Schwartz equation for children)
  • Planned deceased donor kidney transplant from a brain-death (DBD) or circulatory-death (DCD) organ donor expected to occur within the next 24 hours
  • Written informed consent, or consent given by their parent or guardian (if age <18), or other authorised person.

Exclusion Criteria4

  • Planned live donor kidney transplant (except where this is cancelled in favour of transplantation from a deceased donor)
  • Planned multi-organ transplant (dual or en-bloc kidney transplants are not excluded)
  • Be a child with a 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.

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Interventions

Plasma-Lyte Registered Trademark 148 (Plasmalyte) Dose administered - to be determined by the treating physician as a routine intravenous fluid therapy for all maintenance, replacement and resusci

Plasma-Lyte Registered Trademark 148 (Plasmalyte) Dose administered - to be determined by the treating physician as a routine intravenous fluid therapy for all maintenance, replacement and resuscitation purposes. Duration of administration - administered pre-, intra, and post-operatively until fluid is no longer required or 48 hours post-transplant Mode of administration - intravenous


Locations(15)

Royal Prince Alfred Hospital - Camperdown

NSW,QLD,SA,WA,VIC, Australia

Princess Alexandra Hospital - Woolloongabba

NSW,QLD,SA,WA,VIC, Australia

The Royal Adelaide Hospital - Adelaide

NSW,QLD,SA,WA,VIC, Australia

Austin Health - Austin Hospital - Heidelberg

NSW,QLD,SA,WA,VIC, Australia

Westmead Hospital - Westmead

NSW,QLD,SA,WA,VIC, Australia

Prince of Wales Hospital - Randwick

NSW,QLD,SA,WA,VIC, Australia

Fiona Stanley Hospital - Murdoch

NSW,QLD,SA,WA,VIC, Australia

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

NSW,QLD,SA,WA,VIC, Australia

Monash Medical Centre - Clayton campus - Clayton

NSW,QLD,SA,WA,VIC, Australia

Queensland Children's Hospital - South Brisbane

NSW,QLD,SA,WA,VIC, Australia

Sydney Children's Hospital - Randwick

NSW,QLD,SA,WA,VIC, Australia

Sir Charles Gairdner Hospital - Nedlands

NSW,QLD,SA,WA,VIC, Australia

The Children's Hospital at Westmead - Westmead

NSW,QLD,SA,WA,VIC, Australia

Monash Children’s Hospital - Clayton

NSW,QLD,SA,WA,VIC, Australia

Auckland, Christchurch, Wellington, New Zealand

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ACTRN12617000358347