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Buffered bicarbonate solutions for liver transplantation

A randomized, open-label trial non-inferiority study of bicarbonate buffered solution vs Plasmalyte solution fluid therapy during adult liver transplantation

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001227189
Enrollment
52
Registered
2019-09-05
Start date
2021-02-26
Completion date
2022-03-01
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose for this fluid replacement is to maintain normal body homeostasis (balance). The theoretical advantages of a having normal acid-base balance is a lower incidence of postoperative complications i.e. less breathing difficulties, less heart and kidney complications, improvements in time to mobilise, and a shorter duration of hospital stay. During surgery fluid losses can occur from evaporative losses from your skin, losses from your urine, and losses from any bleeding that can result from the surgery. In Australia and most countries in the world, the most commonly used clear fluid to replace any fluid loss during liver transplantation is Plasmalyte solution. This is standard fluid therapy for all patients undergoing liver transplantation at Austin Health. Plasmlayte solution has certain limitations in that it contains certain electrolytes (also called “anions”) that are reliant on the liver for metabolism. During liver transplantation, as the liver does not function normally, this can affect normal “body-balance”. In this study we are investigating whether a clear fluid called “bicarbonate buffered solution” is comparable to Plamalyte solution during transplantation. This solution contains no “anions” and may have a more favourable effect on the “acid-base” balance.

Interventions

Eligible and enrolled patients who are to undergo liver transplantation surgery will receive bicarbonate buffered intravenous solution for all crystalloid fluid therapy during the operation with the volume and dose of crystalloid fluid given at the discretion of the treating clinician with peri-operative fluid charts reviewed to determine administered fluid therapy volumes.

Sponsors

Professor Rinaldo Bellomo
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adult liver donor recipients aged 18 years or older Primary deceased donor liver transplantation including donation after brain death and donation after cardiac death Redo deceased donor liver transplantation

Exclusion criteria

Paediatric recipients aged 17 years of less Combined liver-kidney transplant Combined liver-small bowel transplant Fulminant hepatic failure End stage renal disease defined as a serum creatinine greater than 300 micromol per litre Pregnancy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026