Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000215820
Ethics application status
Approved
Date submitted
17/12/2020
Date registered
3/03/2021
Date last updated
3/03/2021
Date data sharing statement initially provided
3/03/2021
Date results information initially provided
3/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impaired right ventricular deformation to predict acute kidney injury in patients having heart surgery
Scientific title
Right ventricular strain calculated using perioperative trans-oesophageal echocardiography to predict acute kidney injury in patients receiving cardiopulmonary bypass for cardiothoracic surgery
Secondary ID [1] 302501 0
Nil known
Universal Trial Number (UTN)
U1111-1259-3667
Trial acronym
RVS-HIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Right ventricular strain 319358 0
cardiopulmonary bypass 319359 0
Heart surgery 319360 0
Acute kidney injury 319361 0
Condition category
Condition code
Anaesthesiology 317317 317317 0 0
Anaesthetics
Cardiovascular 317318 317318 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is a retrospective analysis of previously captured echocardiographic images of the right ventricle obtained from peri-operative trans-oesophageal echocardiography at the completion of cardiothoracic surgery once patients have been separated from cardiopulmonary bypass. These images are used to determine a numerical value for right ventricular strain. The source of images is from the database of trans-oesophageal echocardiography images obtained as part of the normal care of patients that have undergone cardiac surgery requiring cardiopulmonary bypass at Fiona Stanley Hospital, Perth, WA, Australia between 3rd February 2020 to 3rd August 2020.
Intervention code [1] 318793 0
Not applicable
Comparator / control treatment
There is no control, this is a retrospective analysis taken from images that have already been captured.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325368 0
The development of acute kidney injury as defined by the KDIGO guideline on acute kidney injury identified from the outcomes database that is kept as part of the audit procedure at Fiona Stanley Hospital. This database contains all outcome data for patients undergoing cardiac surgery at Fiona Stanley Hospital. This trial will be using worst acute kidney injury in the first 3 days following cardiac surgery using the KDIGO guideline.
Timepoint [1] 325368 0
Acute kidney injury on the day following heart surgery (as defined by the KDIGO guidelines)
Secondary outcome [1] 387689 0
Oxygen requirement – PaO2/FiO2 ratio

This is defined as the worst PaO2/FiO2 ratio in the three days following cardiac surgery. The data is collected from the cardiac outcomes database for Fiona Stanley hospital.
Timepoint [1] 387689 0
Oxygen requirement – PaO2/FiO2 ratio

This is defined as the worst PaO2/FiO2 ratio in the three days following cardiac surgery. The data is collected from the cardiac outcomes database for Fiona Stanley hospital.
Secondary outcome [2] 391240 0
Conscious level

This is defined as worst GCS score in the three days following cardiac surgery. This information is collected as part of the outcomes auditing at Fiona Stanley Hospital and the source will be this database.
Timepoint [2] 391240 0
This is defined as worst GCS score in the three days following cardiac surgery. This information is collected as part of the outcomes auditing at Fiona Stanley Hospital and the source will be this database.
Secondary outcome [3] 391241 0
Liver function – Bilirubin values at day 5 post op

This is defined as highest bilirubin score in the five days following cardiac surgery. This information is collected as part of the outcomes auditing at Fiona Stanley Hospital and the source will be this database.
Timepoint [3] 391241 0
Liver function – Bilirubin values at day 5 post op

This is defined as highest bilirubin score in the five days following cardiac surgery. This information is collected as part of the outcomes auditing at Fiona Stanley Hospital and the source will be this database.
Secondary outcome [4] 391242 0
Vasopressor/ inotropic requirements
o Requirement and agent when leaving theatre (low cut off threshold of 5mcg/minute Noradrenaline)
o Requirement at 6 hours into ICU stay

This is defined as worst inotrope score in the three days following cardiac surgery. This information is collected as part of the outcomes auditing at Fiona Stanley Hospital and the source will be this database.
Timepoint [4] 391242 0
Vasopressor/ inotropic requirements
o Requirement and agent when leaving theatre (low cut off threshold of 5mcg/minute Noradrenaline)
o Requirement at 6 hours into ICU stay

This is defined as worst inotrope score in the three days following cardiac surgery. This information is collected as part of the outcomes auditing at Fiona Stanley Hospital and the source will be this database.
Secondary outcome [5] 391243 0
RV Strain

Peri-operative RV strain values obtained by TOE images in anaesthetised patients immediately prior to cardiac surgery are not well known. This study will result in a set of values for strain that may be related to outcome.
Timepoint [5] 391243 0
Given that strain values will be taken from TOE images obtained from the pre-knife to skin scans in anaesthetised patients immediately prior to cardiac surgery the timepoints will be Day0 (prior to surgery)

Eligibility
Key inclusion criteria
o Are greater than 18 years old
o Have received cardiothoracic surgery involving cardiopulmonary bypass at Fiona Stanley Hospital in 2020
o Have received a transoesophageal echo as part of their usual care.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No images available as determined by the two trained echocardiographers.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
4/01/2021
Date of last participant enrolment
Anticipated
Actual
29/01/2021
Date of last data collection
Anticipated
31/03/2021
Actual
Sample size
Target
250
Accrual to date
Final
263
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 17801 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 31658 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 306929 0
Charities/Societies/Foundations
Name [1] 306929 0
Heart and Lung Research Institute Western Australia
Country [1] 306929 0
Australia
Funding source category [2] 306930 0
Hospital
Name [2] 306930 0
Fiona Stanley Hospital
Country [2] 306930 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Heart and Lung Research Institute Western Australia
Address
Harry Perkins Institute
5 Robin Warren Dr, Murdoch WA 6150, Australia
Country
Australia
Secondary sponsor category [1] 307489 0
Charities/Societies/Foundations
Name [1] 307489 0
Spinnaker Health Research Foundation
Address [1] 307489 0
Fiona Stanley Hospital
11 Robin Warren Dr, Murdoch WA 6150, Australia
Country [1] 307489 0
Australia
Other collaborator category [1] 281625 0
Individual
Name [1] 281625 0
Dr Warren Pavey
Address [1] 281625 0
Fiona Stanley Hospital
8 Robin Warren Dr, Murdoch WA 6150, Australia
Country [1] 281625 0
Australia
Other collaborator category [2] 281626 0
Individual
Name [2] 281626 0
Dr Mick Scerri
Address [2] 281626 0
Fiona Stanley Hospital
8 Robin Warren Dr, Murdoch WA 6150, Australia
Country [2] 281626 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307076 0
South Metropolitan Health Service- Health Research Ethics Comittee
Ethics committee address [1] 307076 0
South Metropolitan Health Service
Fiona Stanley Hospital,
Education Building
Level 2
11 Robin Warren Drive
Murdoch
WA 6150
Ethics committee country [1] 307076 0
Australia
Date submitted for ethics approval [1] 307076 0
28/09/2020
Approval date [1] 307076 0
28/10/2020
Ethics approval number [1] 307076 0

Summary
Brief summary
This research project is investigating how a right ventricular strain, also known as deformation, obtained during trans-oesophageal echocardiography, may be used to predict kidney failure in patients who are placed on cardiopulmonary bypass for heart and lung surgery. Right ventricular strain may be calculated from echocardiographic images, already taken during heart surgery. Trans-oesophageal ultrasound is an established bedside ultrasound investigation that is used on most patients having heart and lung surgery. Recent technological advancements have allowed us to look at the heart in more detail with the aim of improving the outcomes of these patients.

Kidney failure is a major problem after heart and lung surgery and increases post-operative mortality. It also results in longer hospital stays, invasive investigations, invasive treatments, and may result in the patient needing long term dialysis and transplantation.

Our understanding of how right ventricular strain relates to kidney dysfunction is currently very poor. This research project will improve our understanding and our aim is that this will enable us to direct treatments to preserve kidney function in at risk patients and improve the burden of kidney failure on the patients affected and on the hospitals taking care of them.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105946 0
Dr Richard Hunt
Address 105946 0
Fiona Stanley Hospital
8 Robin Warren Dr, Murdoch WA 6150, Australia
Country 105946 0
Australia
Phone 105946 0
+61491669568
Fax 105946 0
Email 105946 0
[email protected]
Contact person for public queries
Name 105947 0
Dr Richard Hunt
Address 105947 0
Fiona Stanley Hospital
8 Robin Warren Dr, Murdoch WA 6150, Australia
Country 105947 0
Australia
Phone 105947 0
+61 491669568
Fax 105947 0
Email 105947 0
[email protected]
Contact person for scientific queries
Name 105948 0
Dr Richard Hunt
Address 105948 0
Fiona Stanley Hospital
8 Robin Warren Dr, Murdoch WA 6150, Australia
Country 105948 0
Australia
Phone 105948 0
+61491669568
Fax 105948 0
Email 105948 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Demographic, primary and secondary outcome data will be shared if requested.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Access will be granted on a case-by-case basis at the discretion of the Primary Sponsor.
Available for what types of analyses?
To achieve the aims in the approved proposal
How or where can data be obtained?
Access will be subject to approvals by Principal Investigator ([email protected])


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.