Better Evidence for Selecting Transplant Fluids

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.

Conditions

• End Stage Kidney Disease
• Delayed Graft Function
• Kidney Transplant; Complications

Interventions

DRUG

Plasma-Lyte 148 (approx. pH 7.4) IV Infusion

Plasma-Lyte 148 (approx. pH 7.4) IV Infusion is a sterile, clear, non-pyrogenic isotonic solution and when administered intravenously is a source of water, electrolytes and calories. Plasma-Lyte 148 intravenous infusion is indicated as a source of water \& electrolytes or as an alkalinising agent.

DRUG

0.9% SODIUM CHLORIDE 9g/L injection BP

Sodium chloride (0.9% saline) infusion is a sterile, non-pyrogenic solution of sodium chloride in Water for Injections. The concentration of sodium chloride is 154mmol/L. Sodium chloride (0.9%) intravenous infusion is indicated for extra-cellular fluid replacement and in the management of metabolic alkalosis in the presence of fluid loss, and for restoring or maintaining the concentration of sodium and chloride ions.

Sponsors & Collaborators

• Australian Government Department of Health and Ageing

  collaborator OTHER_GOV

• Health Research Council, New Zealand

  collaborator OTHER

• Baxter Healthcare Corporation

  collaborator INDUSTRY

• The University of Queensland

  lead OTHER

Principal Investigators

• Michael Collins, MBChB,FRACP,PhD · Auckland District Health Board & The University of Auckland

• Steven Chadban, BMed(hons),FRACP,PhD · Sydney Local Health District & The University of Sydney

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-26

Primary Completion

2021-07-29

Completion

2022-05-03

Countries

• Australia
• New Zealand

Study Locations