Better Evidence for Selecting Transplant Fluids (BEST-Fluids)

Phase 3

Completed

• Conditions: Delayed graft function in deceased donor kidney recipients.; Renal and Urogenital - Kidney disease; Surgery - Other surgery

• Registration Number: ACTRN12617000358347
• Lead Sponsor: Australasian Kidney Trials Network (University of Qld)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-08
• Study Completion: 2022-05-03
• Last Update Posted: 16 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 808

Inclusion Criteria

1.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)

2.Planned deceased donor kidney transplant from a brain-death (DBD) or circulatory-death (DCD) organ donor expected to occur within the next 24 hours

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 of transplantation from a deceased donor)

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

3.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

4.Known hypersensitivity to the trial fluid preparations or packaging.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of participants with Delayed Graft Function. Measured as receiving treatment with any form of dialysis in the first seven days after transplant collected from ANZDATA[7 days post-transplant]