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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
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Scientific title
A randomized, open-label trial non-inferiority study of bicarbonate buffered solution vs Plasmalyte solution fluid therapy during adult liver transplantation
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Secondary ID [1]
299038
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Liver transplantation
314053
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Condition category
Condition code
Surgery
312442
312442
0
0
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Other surgery
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Oral and Gastrointestinal
312514
312514
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
315311
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Treatment: Drugs
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
321091
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Serum measurement of metabolic acidosis, reflected by standard base excess
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Assessment method [1]
321091
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Timepoint [1]
321091
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5-minutes post reperfusion of the donor liver
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Secondary outcome [1]
373950
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Serum bicarbonate level
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Assessment method [1]
373950
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Timepoint [1]
373950
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5-minutes post liver donor perfusion
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Secondary outcome [2]
373951
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Serum measurement of arterial pH
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Assessment method [2]
373951
0
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Timepoint [2]
373951
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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.
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Secondary outcome [3]
373952
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Serum assessment of arterial blood electrolytes (sodium, potassium, calcium and chloride) as recorded in the patient's medical record.
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Assessment method [3]
373952
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Timepoint [3]
373952
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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.
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Secondary outcome [4]
373953
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intensive care unit admission as recorded in the patient's medical record
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Assessment method [4]
373953
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Timepoint [4]
373953
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duration of intensive care unit admission following liver transplantation as recorded in the patient's medical record
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Blinded allocation using sequence opaque sealed envelops
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Bio-equivalence
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
26/02/2021
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Actual
26/02/2021
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Date of last participant enrolment
Anticipated
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Actual
1/03/2022
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Date of last data collection
Anticipated
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Actual
31/07/2022
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Sample size
Target
52
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Accrual to date
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Final
52
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
14566
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Austin Health - Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
27581
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3084 - Heidelberg
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Funding & Sponsors
Funding source category [1]
303574
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Hospital
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Name [1]
303574
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Austin Hospital
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Address [1]
303574
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145 Studley Road
Heidelberg
Victoria 3084
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Country [1]
303574
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Australia
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Primary sponsor type
Individual
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Name
Professor Rinaldo Bellomo
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Address
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
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Country
Australia
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Secondary sponsor category [1]
303654
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Hospital
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Name [1]
303654
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Austin Health
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Address [1]
303654
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145 Studley Road
Heidelberg
Victoria 3084
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Country [1]
303654
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
304104
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
304104
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Level 8, Harold Stokes Building
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
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Ethics committee country [1]
304104
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Australia
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Date submitted for ethics approval [1]
304104
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26/04/2019
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Approval date [1]
304104
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05/08/2019
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Ethics approval number [1]
304104
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
95822
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Prof Rinaldo Bellomo
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Address
95822
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Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
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Country
95822
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Australia
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Phone
95822
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+61 3 9496 5992
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Fax
95822
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+61 3 9496 3932
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Email
95822
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[email protected]
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Contact person for public queries
Name
95823
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Dr Glenn Eastwood
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Address
95823
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Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
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Country
95823
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Australia
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Phone
95823
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+61 3 9496 4835
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Fax
95823
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+61 3 9496 3932
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Email
95823
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[email protected]
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Contact person for scientific queries
Name
95824
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Prof Rinaldo Bellomo
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Address
95824
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Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
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Country
95824
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Australia
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Phone
95824
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+61 3 9496 5992
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Fax
95824
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+61 3 9496 3932
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Email
95824
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Individual de-identified participant data underlying published results only.
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When will data be available (start and end dates)?
Six months following main results publication; no end date determined.
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Available to whom?
Only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor.
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Available for what types of analyses?
Only to achieve the aims in the approved proposal, for IPD meta-analyses, etc
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How or where can data be obtained?
Principal Investigator of the project via email to the address provided above.
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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.
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