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Trial registered on ANZCTR


Registration number
ACTRN12624001416583p
Ethics application status
Submitted, not yet approved
Date submitted
12/11/2024
Date registered
2/12/2024
Date last updated
2/12/2024
Date data sharing statement initially provided
2/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A registry-based before and after retrospective observational study of change in the renal management of cardiac surgical patients admitted to Australian Intensive Care Units
Scientific title
A registry-based before and after retrospective observational study of change in the renal management of cardiac surgical patients admitted to Australian Intensive Care Units
Secondary ID [1] 313362 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac surgery 335718 0
Acute kidney injury 335837 0
Condition category
Condition code
Cardiovascular 332284 332284 0 0
Coronary heart disease
Cardiovascular 332285 332285 0 0
Other cardiovascular diseases
Renal and Urogenital 332415 332415 0 0
Kidney disease
Surgery 332416 332416 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Years
Description of intervention(s) / exposure
Using data obtained from the Australian & New Zealand Society of Cardiac & Thoracic Surgeons (ANZSCTS) registry we retrospectively collect participant demographics, surgical characteristics, hospital care interventions and complications for the 'after period' which associated amino acid therapy. Specifically, data will be collected annually for the future 3-year period: 1st January 2025 until 31st December 2027.
Intervention code [1] 329944 0
Not applicable
Comparator / control treatment
Using data obtained from the Australian & New Zealand Society of Cardiac & Thoracic Surgeons (ANZSCTS) registry we retrospectively collect participant demographics, surgical characteristics, hospital care interventions and complications for the 'before period' which did not involve the administration of amino acid therapy for the 3 years: 1st January 2022 to 31st December 2024.
Control group
Historical

Outcomes
Primary outcome [1] 339857 0
The occurrence of acute kidney injury within the first week after cardiac surgery, with acute kidney injury defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria for stage 1 or greater acute kidney injury. Stage 1 acute kidney injury is defined as an increase in the serum creatinine level of at least 0.3 mg per decilitre (26.5 micromol per litre) during a 48-hour period or a 50% increase from baseline during a 1-week period, stage 2 as a doubling of the baseline serum creatinine level, and stage 3 as a tripling of the baseline serum creatinine level or the initiation of dialysis, with either occurring within 1 week after the insult (e.g., cardiac surgery).
Timepoint [1] 339857 0
Collected at one-year intervals for 6 years from 1st January 2022 until 31st December 2027.
Secondary outcome [1] 441659 0
In-hospital use of continuous renal-placement therapy from the date of the cardiac surgery through to discharge from hospital.
Timepoint [1] 441659 0
Collected at one-year intervals for 6 years from 1st January 2022 until 31st December 2027.
Secondary outcome [2] 441660 0
In-hospital duration of continuous renal-placement therapy from the date of the cardiac surgery through to discharge from hospital.
Timepoint [2] 441660 0
Collected at one-year intervals for 6 years from 1st January 2022 until 31st December 2027.
Secondary outcome [3] 441661 0
Duration of intensive care unit admission in hours from the time of arrival to the intensive care unit until discharge from the intensive care unit.
Timepoint [3] 441661 0
Collected at one-year intervals for 6 years from 1st January 2022 until 31st December 2027.
Secondary outcome [4] 441662 0
Duration of hospital admission in days from the date of the cardiac surgery through to discharge from hospital.
Timepoint [4] 441662 0
Collected at one-year intervals for 6 years from 1st January 2022 until 31st December 2027.
Secondary outcome [5] 441665 0
Duration of mechanical ventilation in hours from the date of the cardiac surgery through to discharge from hospital.
Timepoint [5] 441665 0
Collected at one-year intervals for 6 years from 1st January 2022 until 31st December 2027.
Secondary outcome [6] 441666 0
Death from any cause documented at the time of ICU discharge, hospital discharge, or 30, 90, or 180 days after the date of cardiac surgery.
Timepoint [6] 441666 0
Collected at one-year intervals for 6 years from 1st January 2022 until 31st December 2027.

Eligibility
Key inclusion criteria
We will include all adult patients who undergoing a cardiac surgical procedure requiring cardiopulmonary bypass and are admitted to an Intensive Care Unit in Australia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
none

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
Analysis following data-linkage will be led by bio-statistician proficient in the analysis of large data sets. Statistical analyses will be performed using R version 4.4.0 (R Foundation for Statistical Computing). Baseline characteristics will be reported as frequencies and percentages, means ? standard deviation, or medians and interquartile ranges. Summary statistics to compare baseline characteristics will include t-test, chi squared test, Fisher exact test, and Wilcoxon rank sum test, as dictated by data type. The primary outcome will be reported using multivariable mixed effects linear regression models. Secondary outcomes will be explored using multivariable linear regression models for continuous outcomes and logistic regression models for binary outcomes. No imputation will be performed for missing data. A two-sided p-value <0.05 will be considered significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2027
Actual
Date of last data collection
Anticipated
31/01/2028
Actual
Sample size
Target
30000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 27315 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 27318 0
St Vincent's Private Hospital - Fitzroy
Recruitment hospital [3] 27319 0
St Vincents & Mercy Private Hospital - Mercy campus - East Melbourne
Recruitment hospital [4] 27320 0
Victorian Heart Hospital - Clayton
Recruitment hospital [5] 27321 0
The Alfred - Melbourne
Recruitment hospital [6] 27322 0
Warringal Private Hospital - Heidelberg
Recruitment hospital [7] 27323 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 43406 0
3084 - Heidelberg
Recruitment postcode(s) [2] 43409 0
3065 - Fitzroy
Recruitment postcode(s) [3] 43410 0
3002 - East Melbourne
Recruitment postcode(s) [4] 43411 0
3168 - Clayton
Recruitment postcode(s) [5] 43412 0
3004 - Melbourne
Recruitment postcode(s) [6] 43413 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 317803 0
Government body
Name [1] 317803 0
Austin Health
Country [1] 317803 0
Australia
Primary sponsor type
Government body
Name
Austin Health
Address
Country
Australia
Secondary sponsor category [1] 320132 0
None
Name [1] 320132 0
Address [1] 320132 0
Country [1] 320132 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316486 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 316486 0
Ethics committee country [1] 316486 0
Australia
Date submitted for ethics approval [1] 316486 0
14/11/2024
Approval date [1] 316486 0
Ethics approval number [1] 316486 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138050 0
Prof Rinaldo Bellomo
Address 138050 0
Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084
Country 138050 0
Australia
Phone 138050 0
+61 394965992
Fax 138050 0
Email 138050 0
rinaldo.bellomo@austin.org.au
Contact person for public queries
Name 138051 0
Rinaldo Bellomo
Address 138051 0
Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084
Country 138051 0
Australia
Phone 138051 0
+61 394965992
Fax 138051 0
Email 138051 0
rinaldo.bellomo@austin.org.au
Contact person for scientific queries
Name 138052 0
Rinaldo Bellomo
Address 138052 0
Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084
Country 138052 0
Australia
Phone 138052 0
+61 394965992
Fax 138052 0
Email 138052 0
rinaldo.bellomo@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
This is a translational of research into practice trial.


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.