Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000005459
Ethics application status
Approved
Date submitted
25/09/2024
Date registered
7/01/2025
Date last updated
7/01/2025
Date data sharing statement initially provided
7/01/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Perioperative kidney assessment to predict acute kidney injury after cardiac surgery in adults
Scientific title
Pre-operative kidney functional REServe and damage biomarkers in PrEdiCTion of perioperative acute kidney injury (AKI) after cardiac surgery (The RESPECTAKI Study) in adults
Secondary ID [1] 313053 0
None
Universal Trial Number (UTN)
Trial acronym
RESPECTAKI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute kidney injury 335278 0
cardiac surgery 335279 0
Condition category
Condition code
Cardiovascular 331850 331850 0 0
Coronary heart disease
Cardiovascular 331851 331851 0 0
Other cardiovascular diseases
Renal and Urogenital 331849 331849 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No intervention.
Exposure is the need of elective cardio thoracic surgery requiring cardiopulmonary bypass in adults.
- what is involved for patients in this study: Recruited patients will have blood and urine samples collected before and after cardiac surgery, for kidney biomarkers measurement. Preoperative assessment also includes an oral protein shake to allow for evaluation of the preoperative kidney functional reserve. Clinical data will be collected from medical records and from the patients.
- what is being observed in participants: postoperative acute kidney injury incidence within the first 3 postoperative days, cardiac and renal complications, long-term kidney function within 1 and 3 years after the surgery, quality of life as per questionnaires.
- the anticipated time required to complete each assessment is: 1. SF36 questionnaire (at the time of first assessment, then online after 1 and 3 months): 15 minutes to complete the questionnaire each time; 2. symptoms questionnaire at day 5-7 after surgery: 5 minutes to complete the questionnaire; 3. preoperative kidney functional reserve test for participants who agree to do it: 6 hours, at a single time before the surgery.
- the overall duration of observation: from time of enrolment for 3 years.
Intervention code [1] 329606 0
Diagnosis / Prognosis
Intervention code [2] 329607 0
Early Detection / Screening
Comparator / control treatment
No control - it is an observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339471 0
Acute Kidney Injury
Timepoint [1] 339471 0
Serum creatinine, urine output and kidney damage biomarkers: daily for the first 3 postoperative days after the cardio thoracic surgery.
Secondary outcome [1] 443461 0
Postoperative symptoms
Timepoint [1] 443461 0
At 5 to 7 days after the surgery
Secondary outcome [2] 443460 0
Quality of life
Timepoint [2] 443460 0
1 month after the cardiac surgery, 3 months after the cardiac surgery,
Secondary outcome [3] 440114 0
Percentage of loss of estimated glomerular filtration rate (eGFR) by CKD-EPI 2021 formula
Timepoint [3] 440114 0
1 month after the cardiac surgery, 3 months after the cardiac surgery, 1 year after the cardiac surgery, 3 years after the cardiac surgery.

Eligibility
Key inclusion criteria
Adult patients undergoing elective cardio thoracic surgery requiring cardiopulmonary bypass.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of malabsorption or chronic inflammatory bowel disease or short bowel syndrome (precluding preoperative assessment using a protein load)
2. History of pancreatic insufficiency (precluding preoperative assessment using a protein load)
3. Chronic Kidney Disease (CKD) stage 5 (eGFR < 15 ml/min/1.73m2)
4. Known pregnancy

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Preoperative Kidney Functional Reserve test and pre and postoperative kidney damage and stress biomarkers will be used as independent variables in a model to predict postoperative AKI by KDIGO criteria within the first 3 postoperative days, using logistic regression models.
Loss of kidney function in long-term (1y and 3y) will be assessed as a continuous variable by using mixed models, potential predictors also include preoperative Kidney Functional Reserve test, pre and postoperative kidney damage and stress biomarkers, in addition to postoperative AKI.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
7/12/2022
Date of last participant enrolment
Anticipated
Actual
1/10/2024
Date of last data collection
Anticipated
1/10/2027
Actual
Sample size
Target
70
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27148 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [2] 27147 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 43227 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 317493 0
Charities/Societies/Foundations
Name [1] 317493 0
Prince of Wales Foundation
Country [1] 317493 0
Australia
Funding source category [2] 317495 0
Charities/Societies/Foundations
Name [2] 317495 0
FAPESP (São Paulo Research Foundation)
Country [2] 317495 0
Brazil
Funding source category [3] 317494 0
Charities/Societies/Foundations
Name [3] 317494 0
Lewis Foundation
Country [3] 317494 0
Australia
Primary sponsor type
Individual
Name
Professor Zoltan Endre, Nephrology Department at Prince of Wales Hospital
Address
Country
Australia
Secondary sponsor category [1] 319788 0
None
Name [1] 319788 0
Address [1] 319788 0
Country [1] 319788 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316206 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 316206 0
Ethics committee country [1] 316206 0
Australia
Date submitted for ethics approval [1] 316206 0
01/09/2021
Approval date [1] 316206 0
14/12/2021
Ethics approval number [1] 316206 0
2021/ETH11409

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

Contacts
Principal investigator
Name 137142 0
Prof Zoltan Endre
Address 137142 0
Prince of Wales Hospital, level 3 - High street, Randwick, NSW, 2031
Country 137142 0
Australia
Phone 137142 0
+61 408 616 776
Fax 137142 0
Email 137142 0
[email protected]
Contact person for public queries
Name 137143 0
Zoltan Endre
Address 137143 0
Prince of Wales Hospital, level 3 - High street, Randwick, NSW, 2031
Country 137143 0
Australia
Phone 137143 0
+61 408 616 776
Fax 137143 0
Email 137143 0
[email protected]
Contact person for scientific queries
Name 137144 0
Zoltan Endre
Address 137144 0
Prince of Wales Hospital, level 3 - High street, Randwick, NSW, 2031
Country 137144 0
Australia
Phone 137144 0
+61 408 616 776
Fax 137144 0
Email 137144 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Scientific community accessing international repositories.

Conditions for requesting access:
• -

What individual participant data might be shared?
• All de-identified data

What types of analyses could be done with individual participant data?
• Any

When can requests for individual participant data be made (start and end dates)?
From:
After study publication, no end limit.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• International repository (https://oaaustralasia.org/institution/csiro/)

Are there extra considerations when requesting access to 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.