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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
2/03/2021
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
Albumin infusion and acute kidney injury (AKI) following cardiac surgery – Randomised Trial
Secondary ID [1] 299299 0
None
Universal Trial Number (UTN)
U1111-1240-3526
Trial acronym
ALBICS
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 6-8 hours of surgery completion, following appropriate consent process and will be administered for 16 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] 374863 0
Tertiary outcome: Peak serum creatinine

Serum creatinine levels will be obtained via routine laboratory investigation, at the frequency determined by the treating team.
Timepoint [5] 374863 0
Within 28 days or before hospital discharge.
Secondary outcome [6] 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 [6] 375145 0
At 24 hours post randomisation.
Secondary outcome [7] 375146 0
Tertiary outcome: Initiation of continuous renal replacement therapy, determined from clinical notes.
Timepoint [7] 375146 0
Within 28 days or before hospital discharge.
Secondary outcome [8] 375147 0
Tertiary outcome: Fluid balance. Determined from medical records.
Timepoint [8] 375147 0
24 and 48 hours from randomisation.
Secondary outcome [9] 375148 0
Tertiary outcome: Quantity of packed red cells transfused, determined from medical records.
Timepoint [9] 375148 0
Within 28 days or before hospital discharge.
Secondary outcome [10] 375149 0
Tertiary outcome: Haemoglobin level

Haemoglobin levels will be obtained via routine laboratory investigation, at the frequency determined by the treating team.
Timepoint [10] 375149 0
at ICU 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
Gender
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
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,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] 14797 0
Barwon Health - Geelong Hospital campus - Geelong
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] 28047 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 303822 0
Hospital
Name [1] 303822 0
Monash Health
Address [1] 303822 0
246 Clayton Road, Clayton VIC 3168
Country [1] 303822 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
246 Clayton Road, Clayton VIC 3168
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
Acute Kidney Injury (AKI) following cardiac surgery is a significant cause of morbidity and mortality, affecting up to 30% of patients. It is unclear if 20% albumin infusion is useful in reducing the incidence of AKI in these patients.

We hypothesise that an infusion of 20% albumin will reduce the incidence of perioperative AKI after high-risk cardiac surgery, compared with standard care.
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
yahya.shehabi@monashhealth.org
Contact person for public queries
Name 96591 0
Mr 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
mayurathan.b@gmail.com
Contact person for scientific queries
Name 96592 0
Mr 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
mayurathan.b@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Recorded patient data for variables of interest, and data dictionaries.
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
To achieve the aims in an approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator.

Contact person:
Mayu Balachandran
mayurathan.b@gmail.com

Principal Investigator:
Yahya Shehabi
yahya.shehabi@monashhealth.org
What supporting documents are/will be available?
No other documents available
Summary results
No Results