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Trial registered on ANZCTR
Registration number
ACTRN12623000726651
Ethics application status
Approved
Date submitted
1/06/2023
Date registered
5/07/2023
Date last updated
5/07/2023
Date data sharing statement initially provided
5/07/2023
Date results information initially provided
5/07/2023
Type of registration
Retrospectively registered
Titles & IDs
Public title
Assessing the impact of blood pressure targets and surgical approach (laparoscopic or open) on continuous urinary oxygenation in patients undergoing general surgical procedures
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Scientific title
Assessing renal blood flow, as measured by urinary oxygenation, acute kidney injury (AKI) and biomarkers of AKI (Nephrocheck) in patients undergoing Laparoscopic and Open General Surgery
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Secondary ID [1]
309804
0
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:
Surgery requiring general anaesthesia
330216
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Condition category
Condition code
Surgery
327083
327083
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0
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Other surgery
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Mean arterial blood pressure target to be within 10% of the patient's pre-operative baseline or above 75 mmHg, whichever was the greater number and to be targeted by the anaesthesiology team using noradreanline and metaraminol vasopressor drugs at doses they deem clinically necessary achieve the targeted blood pressure number after induction and for the duration of the surgical procedure.
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Intervention code [1]
326234
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Treatment: Drugs
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Comparator / control treatment
Mean arterial pressure target of between 65 and 75 mmHg to be targeted by the anaesthesiology team using noradreanline and metaraminol vasopressor drugs at doses they deem clinically necessary achieve the targeted blood pressure number after induction and for the duration of the surgical procedure.
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Control group
Active
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Outcomes
Primary outcome [1]
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Mean urinary oxygen level throughout the first 150 minutes after incision.
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Assessment method [1]
334950
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Timepoint [1]
334950
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Urine oxygen values as measured by sterile fibre optic luminescence optode, measuring urinary oxygen levels every 0.6 seconds from induction and throughout the entire duration of of the surgical procedure according to allocated blood pressure target group.
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Secondary outcome [1]
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Difference in mean urinary oxygen level throughout the first 150 minutes after incision for patients who undergo an open surgical procedure compared with those who undergo a laparoscopic surgical technique
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Assessment method [1]
422526
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Timepoint [1]
422526
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Urine oxygen values as measured by sterile fibre optic luminescence optode, measuring urinary oxygen levels every 0.6 seconds from induction and throughout the entire duration of of the surgical procedure.
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Secondary outcome [2]
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Mean arterial blood pressure during surgery
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Assessment method [2]
423771
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Timepoint [2]
423771
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Difference in mean arterial blood pressure levels assessed via intra-arterial pressure monitoring throughout the first 150 minutes after incision for patients who undergo an open surgical procedure compared with those who undergo a laparoscopic surgical technique
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Secondary outcome [3]
423772
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Incidence of acute kidney injury
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Assessment method [3]
423772
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Timepoint [3]
423772
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Incidence of acute kidney injury defined as either Stage 2 or Stage 3 of the Kidney Disease Improving Global Outcomes (KDIGO) criteria occurring during the first 72-hours after the end of the surgical procedure.
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Secondary outcome [4]
423773
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Neutrophil gelatinase-associated lipocalin assessed biomarker of acute kidney injury.
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Assessment method [4]
423773
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Timepoint [4]
423773
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Evaluation of change in the urinary sample derived acute kidney injury biomarker levels of neutrophil gelatinase-associated lipocalin taken prior to surgery, at the end of the surgical procedural and at 24 hours (the following day post-surgery).
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Eligibility
Key inclusion criteria
Adult patients aged equal to or greater than 18 years of age.
Schedule to have either a laparoscopic or open general surgery
Require placement of a urinary catheter as a part of routine clinical care
Participant provides own consent
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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
Baseline serum creatinine greater than 200µmol.L-1 or an estimated glomerular filtration rate according to the CKD-EPI method below 30ml.min-1.1.73m-2
Patients with acute kidney injury as defined by the KDIGO consensus criteria,
pregnant women
Pre-anaesthetics mean arterial pressure greater than 100mmHg or lower than 65mmHg
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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)
The treatment allocation was placed in an opaque, sealed envelope by an independent party not involved in collecting or analysing the data and given to the clinical anaesthetist.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group allocation was determined by fixed block randomisation of four with a 1:1 allocation generated by a web-based computer random sequence generator (https://www.sealedenvelope.com). The randomisation was stratified according to the laparoscopic or open surgery group.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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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
Safety/efficacy
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Statistical methods / analysis
Descriptive statistics to summarise patient characteristics for each group.
Continuous variables were reported as median with interquartile range (IQR) or mean ± SD as appropriate and categorical variables as proportions.
Linear mixed-effect models to investigate the slope and mean PuO2 differences between the groups.
Models to include random intercepts for both time and patients to account for the repeated measures nature of the data.
Evaluate the first 150 minutes after incision, to represent the mean surgery duration.
Exploratory analyses was divided by the time scale, if necessary, for descriptive purposes.
Difference in arterial blood pressure among the groups assessed by linear mixed models with the same random intercepts.
The model assumptions, including linearity and normality of the residuals, were checked using diagnostics plots.
Sensitivity analysis to estimate the difference in area under the curves (AUC) for PuO2 levels between the groups by a non-parametric bootstrapping procedure.
Statistical analyses were performed using R version 4.2.2 (R Foundation for Statistical Computing).
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
19/10/2020
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Date of last participant enrolment
Anticipated
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Actual
5/10/2022
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Date of last data collection
Anticipated
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Actual
30/03/2023
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Sample size
Target
40
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Accrual to date
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Final
43
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
24824
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Austin Health - Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
40473
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3084 - Heidelberg
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Funding & Sponsors
Funding source category [1]
313988
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Hospital
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Name [1]
313988
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Austin Health
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Address [1]
313988
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Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
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Country [1]
313988
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Australia
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Primary sponsor type
Hospital
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Name
Austin Health
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Address
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
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Country
Australia
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Secondary sponsor category [1]
315870
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Individual
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Name [1]
315870
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Professor Rinaldo Bellomo
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Address [1]
315870
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Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
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Country [1]
315870
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313124
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
313124
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145 Studley Road
Heidelberg
Victoria 3084
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Ethics committee country [1]
313124
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Australia
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Date submitted for ethics approval [1]
313124
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Approval date [1]
313124
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19/03/2020
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Ethics approval number [1]
313124
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HREC/59893/Austin-2019
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Summary
Brief summary
The impact of blood pressure targets and surgical approach (laparoscopic or open) on continuous urinary oxygenation (PuO2), a validated surrogate of renal medullary PO2, during general surgery is unclear. We aimed to assess the effects of different blood pressure targets and surgical procedures on PuO2. In this pilot, single centre, randomised controlled physiological study, patients were allocated to usual mean arterial pressure target management or a slightly higher mean arterial blood pressure target as managed by the treating anesthetists during the operation. The primary outcome was the mean urinary oxygen value during the operation. In doing so, our trial has explored the complex relationship between blood pressure targets, surgical procedures, and renal oxygenation and guide future investigations aiming to personalise renal protective perioperative management stratagies.
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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
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Prof Rinaldo Bellomo
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Address
127082
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Director, Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
VIC 3084
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Country
127082
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Australia
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Phone
127082
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+61 394965992
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Fax
127082
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+61394963932
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Email
127082
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[email protected]
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Contact person for public queries
Name
127083
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Prof Rinaldo Bellomo
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Address
127083
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Director, Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
VIC 3084
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Country
127083
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Australia
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Phone
127083
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+61394965992
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Fax
127083
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+61394963932
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Email
127083
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[email protected]
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Contact person for scientific queries
Name
127084
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Prof Rinaldo Bellomo
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Address
127084
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Director, Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
VIC 3084
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Country
127084
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Australia
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Phone
127084
0
+61394965992
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Fax
127084
0
+61394963932
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Email
127084
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Pilot investigation and findings will be considered hypothesis-generating.
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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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