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Trial registered on ANZCTR


Registration number
ACTRN12619001355167
Ethics application status
Approved
Date submitted
16/09/2019
Date registered
3/10/2019
Date last updated
13/10/2024
Date data sharing statement initially provided
3/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Albumin infusion for kidney protection after heart surgery
Scientific title
Postoperative 20% ALBumin Infusion after Cardiac Surgery for Prevention of Acute Kidney Injury (ALBICS-AKI): a multicentre, randomised controlled trial
Secondary ID [1] 299299 0
None
Universal Trial Number (UTN)
U1111-1240-3526
Trial acronym
ALBICS-AKI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute kidney injury 314426 0
cardiac surgery 314427 0
Condition category
Condition code
Surgery 312768 312768 0 0
Other surgery
Cardiovascular 312769 312769 0 0
Coronary heart disease
Cardiovascular 312770 312770 0 0
Other cardiovascular diseases
Renal and Urogenital 312771 312771 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous infusion of 20% albumin. The infusion will begin within 6 hours of surgery and will be administered for 15 hours at 20mL/hour. The infusion will be given in addition to standard care as per the clinician in charge.

Adherence to the study protocol will be monitored via clinical notes (e.g. ICU observation charts).
Intervention code [1] 315572 0
Treatment: Drugs
Intervention code [2] 315645 0
Prevention
Comparator / control treatment
Standard care as per the clinician incharge. This includes any background treatments considered routine care and may include vasopressors, inotropes, ventilation and initiation of dialysis. Patients in the standard care arm will be permitted to receive 4% albumin fluid but will not be permitted to receive 20% albumin within the first 24hrs following enrolment.
Control group
Active

Outcomes
Primary outcome [1] 321394 0
Incidence of any stage AKI. Serum creatinine levels will be obtained via routine laboratory investigation to determine the occurrence of AKI according to KDIGO criteria.
Timepoint [1] 321394 0
Within 28 days or before hospital discharge, whichever occurs first. Serum creatinine levels will be obtained via routine investigation, at the frequency determined by the treating team.
Secondary outcome [1] 374855 0
Incidence of stage 2 or 3 AKI. Serum creatinine levels will be obtained via routine laboratory investigation to determine the occurrence of AKI according to KDIGO criteria.
Timepoint [1] 374855 0
Within 28 days or before hospital discharge. Serum creatinine levels will be obtained via routine investigation, at the frequency determined by the treating team.
Secondary outcome [2] 374858 0
Mortality
Timepoint [2] 374858 0
Within 28 days or before hospital discharge.
Secondary outcome [3] 374860 0
Length of stay, determined from medical records.
Timepoint [3] 374860 0
In ICU and hospital
Secondary outcome [4] 374861 0
Ventilation time, determined from medical records.
Timepoint [4] 374861 0
Within 28 days or before hospital discharge.
Secondary outcome [5] 375145 0
Tertiary outcome: Albumin level Serum albumin levels will be obtained via routine laboratory investigation, at the frequency determined by the treating team.
Timepoint [5] 375145 0
At 24 hours post randomisation.
Secondary outcome [6] 375146 0
Initiation of continuous renal replacement therapy, determined from clinical notes.
Timepoint [6] 375146 0
Within 28 days or before hospital discharge.
Secondary outcome [7] 375147 0
Tertiary outcome: Fluid balance. Determined from medical records.
Timepoint [7] 375147 0
At the end of the second calendar day.
Secondary outcome [8] 375148 0
Tertiary outcome: Quantity of packed red cells transfused, determined from medical records.
Timepoint [8] 375148 0
At the end of the second calendar day.
Secondary outcome [9] 434585 0
Major Adverse Kidney Events (MAKE). This is a composite outcome of KDIGO defined in-hospital AKI stages II (>100% rise in creatinine) and III (>200% rise in creatinine), requirement for renal replacement therapy, and mortality.
Timepoint [9] 434585 0
Day 28 or hospital discharge
Secondary outcome [10] 434586 0
Vasopressor/inotrope free days
Timepoint [10] 434586 0
Day 28 or hospital discharge
Secondary outcome [11] 434587 0
Vasopressor/inotrope free days
Timepoint [11] 434587 0
Day 14 or hospital discharge
Secondary outcome [12] 434588 0
Tertiary outcome: Occurrence of life-threatening arrhythmia (results in significant haemodynamic compromise, such as supraventricular tachycardia, ventricular tachycardia or fibrillation, atrial fibrillation, sinus pause, and cardiac arrest).
Timepoint [12] 434588 0
Day 14 or hospital discharge
Secondary outcome [13] 434589 0
Tertiary outcome: Occurrence of life-threatening arrhythmia (results in significant haemodynamic compromise, such as supraventricular tachycardia, ventricular tachycardia or fibrillation, atrial fibrillation, sinus pause, and cardiac arrest).
Timepoint [13] 434589 0
Day 28 or hospital discharge

Eligibility
Key inclusion criteria
- Age >18 years of age
- At least one of the following:
i. eGFR <60mL/min/1.73m2; or
ii. Have had a combined valve and coronary procedure; or
iii. 2 valve procedures; or
iv. Surgery involving the thoracic aorta.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients meeting any of the following criteria will be excluded from the study:
- eGFR <15mL/min/1.73m2
- Serum albumin <20g/L
- Dialysis dependence
- Kidney transplant
- Undergoing off-pump coronary bypass surgery
- Requring extra-corporeal life support or ventricular assist device immediately post-operative
- Jehovah’s Witness

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block size 4.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was determined according to the following characteristics:
Anticipated incidence (comparator): 30%
Anticipated incidence (intervention): 20%
Enrolment ratio: 1:1
Alpha: 0.05
Power: 0.8

Data will be analysed using an intention-to-treat methodology.

Normal distribution of continuous data will be assessed. Continuous variables will be expressed as mean ± SD or median (IQR). Differences between the two cohorts of patients will be tested. Categorical variables will be described as frequency (%).

The relative risk (RR) and the median differences (Albumin group vs comparator group), including 95% confidence intervals, will be used to describe the differences of perioperative characteristics, the occurrence of AKI, hospital mortality, and initiation of dialysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/07/2019
Date of last participant enrolment
Anticipated
31/07/2024
Actual
8/08/2024
Date of last data collection
Anticipated
31/08/2024
Actual
5/09/2024
Sample size
Target
620
Accrual to date
Final
621
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 14793 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 14794 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [3] 14795 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [4] 14796 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 26489 0
Victorian Heart Hospital - Clayton
Recruitment hospital [6] 26490 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [7] 26491 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [8] 26492 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 28044 0
3168 - Clayton
Recruitment postcode(s) [2] 28045 0
3144 - Malvern
Recruitment postcode(s) [3] 28046 0
2031 - Randwick
Recruitment postcode(s) [4] 42532 0
3084 - Heidelberg
Recruitment postcode(s) [5] 42533 0
3065 - Fitzroy
Recruitment postcode(s) [6] 42534 0
5042 - Bedford Park
Recruitment outside Australia
Country [1] 26287 0
Italy
State/province [1] 26287 0
Florence

Funding & Sponsors
Funding source category [1] 303822 0
Hospital
Name [1] 303822 0
Monash Health
Country [1] 303822 0
Australia
Funding source category [2] 317619 0
University
Name [2] 317619 0
Institutional funds from the Department of Surgery, School of Clinical Sciences, Monash University.
Country [2] 317619 0
Australia
Funding source category [3] 317620 0
Charities/Societies/Foundations
Name [3] 317620 0
The Prince of Wales Hospital Foundation
Country [3] 317620 0
Australia
Funding source category [4] 317621 0
Commercial sector/Industry
Name [4] 317621 0
Commonwealth Serum Laboratory (CSL-Behring – Australia)
Country [4] 317621 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Road, Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 303948 0
None
Name [1] 303948 0
none
Address [1] 303948 0
Country [1] 303948 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304336 0
Monash Health HREC
Ethics committee address [1] 304336 0
Ethics committee country [1] 304336 0
Australia
Date submitted for ethics approval [1] 304336 0
03/05/2019
Approval date [1] 304336 0
20/05/2019
Ethics approval number [1] 304336 0

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

Contacts
Principal investigator
Name 96590 0
Prof Yahya Shehabi
Address 96590 0
Monash Health, 246 Clayton Road, Clayton VIC 3168
Country 96590 0
Australia
Phone 96590 0
+61 3 9594 6666
Fax 96590 0
Email 96590 0
[email protected]
Contact person for public queries
Name 96591 0
Mayu Balachandran
Address 96591 0
Monash Health, 246 Clayton Road, Clayton VIC 3168
Country 96591 0
Australia
Phone 96591 0
+61 3 9594 3959
Fax 96591 0
Email 96591 0
[email protected]
Contact person for scientific queries
Name 96592 0
Mayu Balachandran
Address 96592 0
Monash Health, 246 Clayton Road, Clayton VIC 3168
Country 96592 0
Australia
Phone 96592 0
+61 3 9594 3959
Fax 96592 0
Email 96592 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:
• Case-by-case basis at the discretion of Primary Sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?
• Recorded patient data for variables of interest, and data dictionaries.

What types of analyses could be done with individual participant data?
• To achieve the aims in an approved proposal

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator.

Contact person:
Dr Mayu Balachandran
[email protected]

Principal Investigator:
Prof Yahya Shehabi
[email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24183Statistical analysis plan    ALBICS-AKI SAP 29Aug2024.docx
24196Statistical analysis plan    29/08/2024 ALBICS-AKI SAP 29Aug2024.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePostoperative 20% albumin vs standard care and acute kidney injury after high-risk cardiac surgery (ALBICS): study protocol for a randomised trial.2021https://dx.doi.org/10.1186/s13063-021-05519-8
N.B. These documents automatically identified may not have been verified by the study sponsor.