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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
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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
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Secondary ID [1]
313053
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None
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Universal Trial Number (UTN)
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Trial acronym
RESPECTAKI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
acute kidney injury
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cardiac surgery
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Condition category
Condition code
Cardiovascular
331850
331850
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0
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Coronary heart disease
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Cardiovascular
331851
331851
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0
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Other cardiovascular diseases
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Renal and Urogenital
331849
331849
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0
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Kidney disease
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
329606
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Diagnosis / Prognosis
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Intervention code [2]
329607
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Early Detection / Screening
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Comparator / control treatment
No control - it is an observational study
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Acute Kidney Injury
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Assessment method [1]
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The Kidney Disease: Improving Global Outcomes (KDIGO) criteria: an increase in serum creatinine (sCr) by 1.5 X its baseline value within 7 days, or by an increase in sCr by >=26.5 umol/L within 2 days, or a decrease in urine output (UO) of < 0.5ml/kg/h for a minimum of 6h.
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Timepoint [1]
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Serum creatinine, urine output and kidney damage biomarkers: daily for the first 3 postoperative days after the cardio thoracic surgery.
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Secondary outcome [1]
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Postoperative symptoms
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Assessment method [1]
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Edmonton Symptom Assessment System (ESAS) questionnaire
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Timepoint [1]
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At 5 to 7 days after the surgery
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Secondary outcome [2]
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Quality of life
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Assessment method [2]
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SF-36 questionnaire
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Timepoint [2]
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1 month after the cardiac surgery, 3 months after the cardiac surgery,
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Secondary outcome [3]
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Percentage of loss of estimated glomerular filtration rate (eGFR) by CKD-EPI 2021 formula
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Assessment method [3]
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Blood test assessing plasma creatinine before and after the surgery. Then eGFR is determined by using a formula (CKD-EPI 2021 formula). The percentage of loss of eGFR will be defined as: [(preoperative eGFR - postoperative eGFR at determined timepoint)/preoperative eGFR] x 100
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Timepoint [3]
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1 month after the cardiac surgery, 3 months after the cardiac surgery, 1 year after the cardiac surgery, 3 years after the cardiac surgery.
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Eligibility
Key inclusion criteria
Adult patients undergoing elective cardio thoracic surgery requiring cardiopulmonary bypass.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Convenience sample
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Timing
Prospective
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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.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
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Actual
7/12/2022
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Date of last participant enrolment
Anticipated
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Actual
1/10/2024
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Date of last data collection
Anticipated
1/10/2027
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Actual
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Sample size
Target
70
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Accrual to date
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Final
68
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Prince of Wales Private Hospital - Randwick
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Recruitment hospital [2]
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Prince of Wales Hospital - Randwick
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Recruitment postcode(s) [1]
43227
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2031 - Randwick
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Prince of Wales Foundation
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Address [1]
317493
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Country [1]
317493
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Australia
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Funding source category [2]
317495
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Charities/Societies/Foundations
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Name [2]
317495
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FAPESP (São Paulo Research Foundation)
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Address [2]
317495
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Country [2]
317495
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Brazil
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Funding source category [3]
317494
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Charities/Societies/Foundations
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Name [3]
317494
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Lewis Foundation
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Address [3]
317494
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Country [3]
317494
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Australia
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Primary sponsor type
Individual
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Name
Professor Zoltan Endre, Nephrology Department at Prince of Wales Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
319788
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Address [1]
319788
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Country [1]
319788
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316206
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South Eastern Sydney Local Health District HREC
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Ethics committee address [1]
316206
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https://www.seslhd.health.nsw.gov.au/services-clinics/directory/research-home/ethics
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Ethics committee country [1]
316206
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Australia
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Date submitted for ethics approval [1]
316206
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01/09/2021
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Approval date [1]
316206
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14/12/2021
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Ethics approval number [1]
316206
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2021/ETH11409
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Summary
Brief summary
In this prospective observational study, adult participants undergoing elective cardio thoracic surgery requiring cardiopulmonary bypass are assessed preoperatively by a kidney functional reserve test and by kidney damage biomarkers (i.e., urine DKK3) and postoperatively by kidney damage and stress biomarkers (i.e., urine KIM-1, urine NGAL, urine Nephrocheck) for the first 3 postoperative days. These will be assessed as predictors of AKI as per KDIGO guidelines within the first 3 postoperative days. Kidney function will be assessed by serum creatinine within 1 and 3 years after the surgery. The hypothesis is that the suggested preoperative assessment will help to identify people at higher risk of developing postoperative AKI and that postoperative AKI defined by kidney damage and stress biomarkers will identify people at higher risk of developing worsening kidney function at long-term (i.e.: 1 and 3 years after the surgery).
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Zoltan Endre
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Address
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Prince of Wales Hospital, level 3 - High street, Randwick, NSW, 2031
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Country
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Australia
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Phone
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+61 408 616 776
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Zoltan Endre
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Address
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Prince of Wales Hospital, level 3 - High street, Randwick, NSW, 2031
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Country
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Australia
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Phone
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+61 408 616 776
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Zoltan Endre
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Address
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Prince of Wales Hospital, level 3 - High street, Randwick, NSW, 2031
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Country
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Australia
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Phone
137144
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+61 408 616 776
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Fax
137144
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Email
137144
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[email protected]
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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:
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Scientific community accessing international repositories.
Conditions for requesting access:
•
-
What individual participant data might be shared?
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All de-identified data
What types of analyses could be done with individual participant data?
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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.
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