Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001227189
Ethics application status
Approved
Date submitted
16/08/2019
Date registered
5/09/2019
Date last updated
17/08/2022
Date data sharing statement initially provided
5/09/2019
Date results information initially provided
17/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Buffered bicarbonate solutions for liver transplantation
Scientific title
A randomized, open-label trial non-inferiority study of bicarbonate buffered solution vs Plasmalyte solution fluid therapy during adult liver transplantation
Secondary ID [1] 299038 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver transplantation 314053 0
Condition category
Condition code
Surgery 312442 312442 0 0
Other surgery
Oral and Gastrointestinal 312514 312514 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 315311 0
Treatment: Drugs
Comparator / control treatment
Eligible and enrolled patients who are to undergo liver transplantation surgery will receive Plasmalyte 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.
Control group
Active

Outcomes
Primary outcome [1] 321091 0
Serum measurement of metabolic acidosis, reflected by standard base excess
Timepoint [1] 321091 0
5-minutes post reperfusion of the donor liver
Secondary outcome [1] 373950 0
Serum bicarbonate level
Timepoint [1] 373950 0
5-minutes post liver donor perfusion
Secondary outcome [2] 373951 0
Serum measurement of arterial pH
Timepoint [2] 373951 0
At the commencement of the operation, approximately 45-minutely during and at the end of the operation where an arterial blood gas is measured as part of routine intraoperative care.
Secondary outcome [3] 373952 0
Serum assessment of arterial blood electrolytes (sodium, potassium, calcium and chloride) as recorded in the patient's medical record.
Timepoint [3] 373952 0
At the commencement of the operation, approximately 45-minutely during and at the end of the operation where an arterial blood gas is measured as part of routine intraoperative care.
Secondary outcome [4] 373953 0
intensive care unit admission as recorded in the patient's medical record
Timepoint [4] 373953 0
duration of intensive care unit admission following liver transplantation as recorded in the patient's medical record

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Blinded allocation using sequence opaque sealed envelops
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis
Statistical analysis will be performed using commercial statistical software, with a p value of 0.05 to indicate statistical significance. Outcomes will be compared after log transformation where appropriate. Comparisons will be made using t-test and ANOVA for repeated-measures or Wilcoxon rank-signed test and Kruskall-Wallis according to the underlying distribution for continuous data and Chi-square for categorical data.
When there are baseline imbalances, logistic regression analysis will also be performed to adjust for them. Analysis will be on an intention-to-treat basis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/02/2021
Actual
26/02/2021
Date of last participant enrolment
Anticipated
Actual
1/03/2022
Date of last data collection
Anticipated
Actual
31/07/2022
Sample size
Target
52
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14566 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 27581 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 303574 0
Hospital
Name [1] 303574 0
Austin Hospital
Country [1] 303574 0
Australia
Primary sponsor type
Individual
Name
Professor Rinaldo Bellomo
Address
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 303654 0
Hospital
Name [1] 303654 0
Austin Health
Address [1] 303654 0
145 Studley Road
Heidelberg
Victoria 3084
Country [1] 303654 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304104 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 304104 0
Level 8, Harold Stokes Building
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Ethics committee country [1] 304104 0
Australia
Date submitted for ethics approval [1] 304104 0
26/04/2019
Approval date [1] 304104 0
05/08/2019
Ethics approval number [1] 304104 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95822 0
Prof Rinaldo Bellomo
Address 95822 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 95822 0
Australia
Phone 95822 0
+61 3 9496 5992
Fax 95822 0
+61 3 9496 3932
Email 95822 0
rinaldo.bellomo@austin.org.au
Contact person for public queries
Name 95823 0
Dr Glenn Eastwood
Address 95823 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 95823 0
Australia
Phone 95823 0
+61 3 9496 4835
Fax 95823 0
+61 3 9496 3932
Email 95823 0
glenn.eastwood@austin.org.au
Contact person for scientific queries
Name 95824 0
Prof Rinaldo Bellomo
Address 95824 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 95824 0
Australia
Phone 95824 0
+61 3 9496 5992
Fax 95824 0
+61 3 9496 3932
Email 95824 0
rinaldo.bellomo@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual de-identified participant data underlying published results only.
When will data be available (start and end dates)?
Six months following main results publication; no end date determined.
Available to whom?
Only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Only to achieve the aims in the approved proposal, for IPD meta-analyses, etc
How or where can data be obtained?
Principal Investigator of the project via email to the address provided above.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.