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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 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

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

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Surgery requiring general anaesthesia

Condition category

Condition code

Surgery

Other surgery

Intervention/exposure

Study type

Interventional

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.

Intervention code [1]

Treatment: Drugs

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.

Control group

Active

Outcomes

Primary outcome [1]

Mean urinary oxygen level throughout the first 150 minutes after incision.

Timepoint [1]

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.

Secondary outcome [1]

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

Timepoint [1]

Secondary outcome [2]

Mean arterial blood pressure during surgery

Timepoint [2]

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

Secondary outcome [3]

Incidence of acute kidney injury

Timepoint [3]

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.

Secondary outcome [4]

Neutrophil gelatinase-associated lipocalin assessed biomarker of acute kidney injury.

Timepoint [4]

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).

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

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

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

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)

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.

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.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Phase 2

Type of endpoint/s

Safety/efficacy

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).

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

19/10/2020

Date of last participant enrolment

Anticipated

Actual

5/10/2022

Date of last data collection

Anticipated

Actual

30/03/2023

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Austin Health

Address [1]

Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Professor Rinaldo Bellomo

Address [1]

Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

145 Studley Road
Heidelberg
Victoria 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

19/03/2020

Ethics approval number [1]

HREC/59893/Austin-2019

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Rinaldo Bellomo

Address

Director, Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
VIC 3084

Country

Australia

Phone

+61 394965992

Fax

+61394963932

rinaldo.bellomo@austin.org.au

Contact person for public queries

Name

Rinaldo Bellomo

Address

Director, Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
VIC 3084

Country

Australia

Phone

+61394965992

Fax

+61394963932

rinaldo.bellomo@austin.org.au

Contact person for scientific queries

Name

Rinaldo Bellomo

Address

Director, Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg
VIC 3084

Country

Australia

Phone

+61394965992

Fax

+61394963932

rinaldo.bellomo@austin.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Pilot investigation and findings will be considered hypothesis-generating.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Current Study Results

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		Nil available as currently under peer-review

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
3748	Study results article	Yes	https://doi.org/10.1007/s10877-023-01079-1	Cite this article Chaba, A., Hacking, D., Slifi... [More Details]

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

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