Better Evidence for Selecting Transplant Fluids

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Queensland
• Collaborators: Australian Government Department of Health; Australian Government Department of Health and Ageing; Baxter Healthcare Corporation; Health Research Council, New Zealand
• Treatments: Pharmaceutical Solutions; Plasma-lyte 148

Criteria

Inclusion Criteria:

1. 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

2. Planned deceased donor kidney transplant from a brain-death (DBD) or circulatory-death (DCD) organ donor within 24 hours, AND

3. Written informed consent, or consent given by their parent or guardian (if age <18), or other authorised person

Exclusion Criteria:

1. Planned live donor kidney transplant (except where this is cancelled in favour or transplantation from a deceased donor)

2. Planned multi-organ transplant (dual or en-bloc kidney transplants are not excluded)

3. 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

4. Known hypersensitivity to the trial fluid preparations or packaging