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Trial registered on ANZCTR


Registration number
ACTRN12619001488190
Ethics application status
Approved
Date submitted
28/09/2019
Date registered
29/10/2019
Date last updated
2/12/2019
Date data sharing statement initially provided
29/10/2019
Date results information initially provided
29/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Changes in blood potassium levels in adult patients undergoing liver transplantation
Scientific title
Peak serum potassium levels during reperfusion in adult patients undergoing primary cadaveric liver transplantation
Secondary ID [1] 299434 0
None
Universal Trial Number (UTN)
U1111-1241-1752
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperkalaemia 314629 0
Liver transplantation 314630 0
Anaesthesia 314631 0
Condition category
Condition code
Anaesthesiology 312966 312966 0 0
Anaesthetics
Surgery 312967 312967 0 0
Surgical techniques
Blood 312968 312968 0 0
Other blood disorders
Metabolic and Endocrine 312969 312969 0 0
Other metabolic disorders
Cardiovascular 312970 312970 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
There is no participant involvement as this is a retrospective review of the patient medical records. The medical records of thirty consecutive patients undergoing primary cadaveric liver transplantation will be retrospectively evaluated. From this retrospective cohort we will use the hospital electronic medical record system (CERNER) to identify the blood potassium levels during reperfusion of the donor liver in patients undergoing primary cadaveric liver transplantation. Hyperkalaemia, defined according to international criteria, is a serum potassium above 5.5 mol/L. The duration of observation per participant is from admission to hospital to discharge from hospital. The is no collection of data for the post discharge period.
Intervention code [1] 315681 0
Early Detection / Screening
Intervention code [2] 315682 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321543 0
The primary outcome is the highest absolute change in serum potassium during reperfusion of the donor liver. The intraoperative plasma potassium value will be recorded by an arterial blood gas, which is routinely sampled during this stage of surgery. Measurement of plasma potassium levels in arterial blood will be measured using an ABL 800 Blood Gas Analyser (Radiometer, Copenhagen, Denmark) with a fully automated micromode eliminating the risk of user induced bias or loss of accuracy with very small samples. The potassium value from the blood gas machine will be stored electronically on our hospital's electronic medical record system (Cerner). This value will be extracted onto a data collection form.
Timepoint [1] 321543 0
5 minutes after perfusion of the donor liver
Secondary outcome [1] 375317 0
The number of patients who develop hyperkalaemia during reperfusion of the donor liver. This outcome will be assessed by reviewing the medical records.
Timepoint [1] 375317 0
Five minutes are perfusion of the donor liver
Secondary outcome [2] 375318 0
The absolute changes in serum potassium from baseline values during reperfusion of the donor liver. The intraoperative plasma potassium values will be recorded by an arterial blood gas, which is routinely sampled during this stage of surgery. Measurement of plasma potassium levels in arterial blood will be measured using an ABL 800 Blood Gas Analyser (Radiometer, Copenhagen, Denmark) with a fully automated micromode eliminating the risk of user induced bias or loss of accuracy with very small samples. The potassium value from the blood gas machine will be stored electronically on our hospital's electronic medical record system (Cerner). This value will be extracted onto a data collection form.
Timepoint [2] 375318 0
Five minutes after perfusion of the donor liver
Secondary outcome [3] 375319 0
The time to peak serum potassium levels during reperfusion of the donor liver. The intraoperative plasma potassium value will be recorded by an arterial blood gas, which is routinely sampled during this stage of surgery. Measurement of plasma potassium levels in arterial blood will be measured using an ABL 800 Blood Gas Analyser (Radiometer, Copenhagen, Denmark) with a fully automated micromode eliminating the risk of user induced bias or loss of accuracy with very small samples. The potassium value from the blood gas machine will be stored electronically on our hospital's electronic medical record system (Cerner). This value will be extracted onto a data collection form.
Timepoint [3] 375319 0
Five minutes after perfusion of the donor liver
Secondary outcome [4] 375320 0
Electrocardiograph (ECG) changes of hyperkalaemia. This composite outcome will be assessed by reviewing the continuous ECG rhythm strip during the reperfusion period. A detailed review of the following chronological ECG changes of hyperkalemia will be assesed: peaked T waves, prolongation of PR interval, widening QRS Complex, loss of P wave, “sine wave”, and asystole. The ECGs will be reviewed by two independent cardiologists who will be blinded to serum potassium values of each participant.
Timepoint [4] 375320 0
Five minutes after perfusion of the donor liver
Secondary outcome [5] 375321 0
This will be a composite outcome to assess any correlation between changes in serum potassium levels during reperfusion and the following a-priori variables: MELD (Model of End Stage Liver Disease) score, cold and warm ischaemia times, total vasopressor use at the time of reperfusion, and potassium effluent levels of the donor liver.
Timepoint [5] 375321 0
Five minutes after perfusion of the donor liver
Secondary outcome [6] 375322 0
Intraopertive fluid use. This will be the total volume in millilitres of all crystalloid, colloid and blood or blood products administered during surgery. This outcome will be assessed by reviewing the medical records.
Timepoint [6] 375322 0
From the beginning of surgery (defined as skin incision) to completion of surgery (defined as last surgical suture).
Secondary outcome [7] 375323 0
Use of vasoactive medication during surgery. A vasoactive medication will be defined any vasoactive drug or inotrope. These will include noradrenalin, adrenalin, vasopressin, methylene blue, metaraminol, ephedrine, dopamine or dobutamine. This outcome will be assessed by reviewing the medical records.
Timepoint [7] 375323 0
From the beginning of surgery (defined as skin incision) to completion of surgery (defined as last surgical suture).
Secondary outcome [8] 375324 0
Length of hospital stay
Timepoint [8] 375324 0
From completion of surgery until hospital discharge. This will be assessed from data linkage to the patients electronic medical records (CERNER) and from the patients discharge summary on the electronic medical records.
Secondary outcome [9] 375325 0
In patient mortality. This will be assessed from data linkage to the patients electronic medical records (CERNER) which captures any mortality within the index hospital admission.
Timepoint [9] 375325 0
From completion of surgery until death

Eligibility
Key inclusion criteria
Inclusion criteria will be adult patients (>18 years of age) undergoing primary cadaveric orthotopic liver transplantation. .
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We will exclude the following patients:
1. Patients undergoing multiorgan transplant
2. Pregnancy
3. Patients with fulminant liver failure.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Continuously distributed data will be tested for normality and measures of central tendency will be analysed. Normally distributed data will be expressed as means and standard deviations and compared using a Student t-test; non-normally distributed data will be expressed as medians (interquartile range, IQR) and compared using the Mann-Whitney U test. Categorical variables will be described as proportions and compared using the chi-squared test or the Fisher Exact test. The strength of the relationship and association between the changes in serum potassium levels and the a-priori variables will be evaluated with the Spearman rank correlation coefficient. All p-values of less than 0.05 will be treated as indicative as statistical significance and no correction for multiplicity of testing will be undertaken due to the exploratory nature of the study. The study will be reported using the STROBE guidelines (Strengthening the Reporting of Observation studies in Epidemiology). Analyses will be performed using GraphPad Prism (version 7.00 for Mac, GraphPad Software, La Jolla California USA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14891 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 28159 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 303944 0
Hospital
Name [1] 303944 0
Austin Health
Address [1] 303944 0
145 Studley Road, Heidlelberg, 3084, Victoria
Country [1] 303944 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road, Heidlelberg, 3084, Victoria
Country
Australia
Secondary sponsor category [1] 304097 0
None
Name [1] 304097 0
Address [1] 304097 0
Country [1] 304097 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304443 0
Austin Health Reserach Ethics Committee
Ethics committee address [1] 304443 0
145 Studley Road, Austin Health, Heidlelberg, 3084, Victoria
Ethics committee country [1] 304443 0
Australia
Date submitted for ethics approval [1] 304443 0
09/04/2018
Approval date [1] 304443 0
16/05/2018
Ethics approval number [1] 304443 0
LNR/18/Austin/250

Summary
Brief summary
The purpose of this study is to identify the time point of peak serum potassium levels during the reperfusion phase of adult liver transplantation. We aim to assess the the changes in blood potassium levels from baseline values during reperfusion, and evaluate clinical factors that may be associated with the development of hyperkalaemia.

Who is it for?

This is a retrospective study evaluating potassium levels in adult patients undergoing primary orthotropic liver transplantation.

Study details

The aim of this study is to quantify the changes in potassium during the reperfusion phase of liver transplantation. Elevated recipient serum potassium levels have been identified as an independent risk factor for post-operative mortality in liver transplantation. Further, severe hyperkalemia at reperfusion can result in cardiac arrhythmias and cardiac asystole if not adequately monitored and treated.

We consider the incidence and severity of hyperkalaemia in this setting. In addition, we will highlight the importance of evaluating the changes in potassium relevant to patients undergoing liver transplantation.

It is hoped that this study will be hypothesis generating and provide valuable data for power calculations for future studies on evaluating changes in potassium values during reperfusion. Further, we will provide an in-depth insight of the changes in serum potassium levels during the reperfusion stage to guide clinicians caring for such patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96962 0
A/Prof Laurence Weinberg
Address 96962 0
145 Studley Road Heidelberg VIC 3084
Department of Anaesthesia, Austin Health
Country 96962 0
Australia
Phone 96962 0
+61 3 94965000
Fax 96962 0
+61 3 9459 6421
Email 96962 0
laurence.weinberg@austin.org.au
Contact person for public queries
Name 96963 0
A/Prof Laurence Weinberg
Address 96963 0
145 Studley Road Heidelberg VIC 3084
Department of Anaesthesia, Austin Health
Country 96963 0
Australia
Phone 96963 0
+61 3 94965000
Fax 96963 0
+61 3 9459 6421
Email 96963 0
laurence.weinberg@austin.org.au
Contact person for scientific queries
Name 96964 0
A/Prof Laurence Weinberg
Address 96964 0
145 Studley Road Heidelberg VIC 3084
Department of Anaesthesia, Austin Health
Country 96964 0
Australia
Phone 96964 0
+61 3 94965000
Fax 96964 0
+61 3 9459 6421
Email 96964 0
laurence.weinberg@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patients have no consented to sharing of their data
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 5133 0
Ethical approval
Citation [1] 5133 0
Link [1] 5133 0
Email [1] 5133 0
Other [1] 5133 0
Type [2] 5134 0
Ethical approval
Citation [2] 5134 0
Link [2] 5134 0
Email [2] 5134 0
Other [2] 5134 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary