Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000467437p
Ethics application status
Submitted, not yet approved
Date submitted
23/04/2025
Date registered
16/05/2025
Date last updated
16/05/2025
Date data sharing statement initially provided
16/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of randomization to different flow targets for cardiopulmonary bypass.
Scientific title
Feasibility of randomization to different flow targets for cardiopulmonary bypass in patients undergoing cardiac surgery
Secondary ID [1] 314262 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute kidney injury 337194 0
cardiovascular disease 337191 0
cardiac surgery 337193 0
cardiopulmonary bypass 337192 0
Condition category
Condition code
Surgery 333695 333695 0 0
Surgical techniques
Cardiovascular 333605 333605 0 0
Other cardiovascular diseases
Renal and Urogenital 333604 333604 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Targeted cardiouplmonary bypass flows of 2.8 L/min/m^2 of Body surface area for the entire duration of cardiopulmonary bypass for cardiac surgery, which may vary from less than 45 minutes to more than 180 minutes, depending on surgical complexity.

This will be performed by the perfusionist running the cardiopulmonary bypass machine.

Adherence will be assessed as part of the primary outcome through interrogation of the bypass machine records.
Intervention code [1] 330872 0
Treatment: Other
Comparator / control treatment
Targeted cardiouplmonary bypass flows of 2.4 L/min/m^2 of Body surface area for the entire duration of cardiopulmonary bypass for cardiac surgery, which may vary from less than 45 minutes to more than 180 minutes, depending on surgical complexity.

This will be performed by the perfusionist running the cardiopulmonary bypass machine.

Adherence will be assessed as part of the primary outcome through interrogation of the bypass machine records.
Control group
Active

Outcomes
Primary outcome [1] 341182 0
Feasibility. This will be defined as: ->80% of time on cardiopulmonary bypass where flow targets were maintained; OR group separation of >0.4 litres per minute per metre squared of body surface area for >80% of time on cardiopulmonary bypass. AND - >80% of time on cardiopulmonary bypass in both groups where indexed delivery of oxygen is >280ml oxygen per minute per metre squared of body surface area. AND - >80% of creatinine data captured for 3 consecutive postoperative days for both groups.
Timepoint [1] 341182 0
During cardiopulmonary bypass and within 3 days postoperative
Secondary outcome [1] 446681 0
Randomisation to eligibility ratio
Timepoint [1] 446681 0
At conclusion of study (1 month post last participant randomisation).
Secondary outcome [2] 446680 0
Eligibility to screening ratio
Timepoint [2] 446680 0
At conclusion of study (1 month post last participant randomisation).

Eligibility
Key inclusion criteria
>18 years of age
- Undergoing cardiac surgery involving cardiopuplmonary bypass
- Planned temperature >32°C during cardioplmonary bypass
- Estimated glomerular filtration rate (eGFR) >30ml/min/1.73m^2 of body surface area (BSA)
- Lowest anticipated indexed systemic delivery of oxygen (DO2i) of >280 ml/L/m2 of BSA (based on weight, pre-op haemoglobin and 1500mL prime volume)
- Able to consent for participation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnancy
- Failure to meet any inclusion criteria

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
1/10/2027
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC

Funding & Sponsors
Funding source category [1] 318783 0
Other
Name [1] 318783 0
Australian and New Zealand College of Anaesthetist Project Grant
Country [1] 318783 0
Australia
Primary sponsor type
Individual
Name
Raymond Hu, Austin Health
Address
Country
Australia
Secondary sponsor category [1] 321222 0
None
Name [1] 321222 0
Address [1] 321222 0
Country [1] 321222 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317391 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 317391 0
Ethics committee country [1] 317391 0
Australia
Date submitted for ethics approval [1] 317391 0
12/05/2025
Approval date [1] 317391 0
Ethics approval number [1] 317391 0

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

Contacts
Principal investigator
Name 140906 0
Dr Raymond Hu
Address 140906 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg, Victoria 3084
Country 140906 0
Australia
Phone 140906 0
+61 3 9496 3800
Fax 140906 0
Email 140906 0
[email protected]
Contact person for public queries
Name 140907 0
Raymond Hu
Address 140907 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg, Victoria 3084
Country 140907 0
Australia
Phone 140907 0
+61 3 9496 3800
Fax 140907 0
Email 140907 0
[email protected]
Contact person for scientific queries
Name 140908 0
Raymond Hu
Address 140908 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg, Victoria 3084
Country 140908 0
Australia
Phone 140908 0
+61 3 9496 3800
Fax 140908 0
Email 140908 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.