ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

cardiac surgery

Condition category

Condition code

Surgery

Other surgery

Cardiovascular

Coronary heart disease

Cardiovascular

Other cardiovascular diseases

Renal and Urogenital

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]

Treatment: Drugs

Intervention code [2]

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]

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]

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]

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]

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]

Mortality

Timepoint [2]

Within 28 days or before hospital discharge.

Secondary outcome [3]

Length of stay, determined from medical records.

Timepoint [3]

In ICU and hospital

Secondary outcome [4]

Ventilation time, determined from medical records.

Timepoint [4]

Within 28 days or before hospital discharge.

Secondary outcome [5]

Tertiary outcome: Albumin level

Serum albumin levels will be obtained via routine laboratory investigation, at the frequency determined by the treating team.

Timepoint [5]

At 24 hours post randomisation.

Secondary outcome [6]

Initiation of continuous renal replacement therapy, determined from clinical notes.

Timepoint [6]

Within 28 days or before hospital discharge.

Secondary outcome [7]

Tertiary outcome: Fluid balance. Determined from medical records.

Timepoint [7]

At the end of the second calendar day.

Secondary outcome [8]

Tertiary outcome: Quantity of packed red cells transfused, determined from medical records.

Timepoint [8]

At the end of the second calendar day.

Secondary outcome [9]

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]

Secondary outcome [10]

Timepoint [10]

Day 28 or hospital discharge

Secondary outcome [11]

Vasopressor/inotrope free days

Timepoint [11]

Day 28 or hospital discharge

Secondary outcome [12]

Vasopressor/inotrope free days

Timepoint [12]

Day 14 or hospital discharge

Secondary outcome [13]

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]

Day 14 or hospital discharge

Secondary outcome [14]

Timepoint [14]

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?

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]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [2]

Cabrini Hospital - Malvern - Malvern

Recruitment hospital [3]

Prince of Wales Private Hospital - Randwick

Recruitment hospital [4]

Prince of Wales Hospital - Randwick

Recruitment hospital [5]

Victorian Heart Hospital - Clayton

Recruitment hospital [6]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [7]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment hospital [8]

Flinders Medical Centre - Bedford Park

Recruitment postcode(s) [1]

3168 - Clayton

Recruitment postcode(s) [2]

3144 - Malvern

Recruitment postcode(s) [3]

2031 - Randwick

Recruitment postcode(s) [4]

3084 - Heidelberg

Recruitment postcode(s) [5]

3065 - Fitzroy

Recruitment postcode(s) [6]

5042 - Bedford Park

Recruitment outside Australia

Country [1]

Italy

State/province [1]

Florence

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Monash Health

Address [1]

246 Clayton Road, Clayton VIC 3168

Country [1]

Australia

Funding source category [2]

University

Name [2]

Institutional funds from the Department of Surgery, School of Clinical Sciences, Monash University.

Address [2]

Country [2]

Australia

Funding source category [3]

Charities/Societies/Foundations

Name [3]

The Prince of Wales Hospital Foundation

Address [3]

Country [3]

Australia

Funding source category [4]

Commercial sector/Industry

Name [4]

Commonwealth Serum Laboratory (CSL-Behring – Australia)

Address [4]

Country [4]

Australia

Primary sponsor type

Hospital

Name

Monash Health

Address

246 Clayton Road, Clayton VIC 3168

Country

Australia

Secondary sponsor category [1]

None

Name [1]

none

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health HREC

Ethics committee address [1]

246 Clayton Road, Clayton VIC 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/05/2019

Approval date [1]

20/05/2019

Ethics approval number [1]

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

Prof Yahya Shehabi

Address

Monash Health,
246 Clayton Road, Clayton VIC 3168

Country

Australia

Phone

+61 3 9594 6666

Fax

[email protected]

Contact person for public queries

Name

Mayu Balachandran

Address

Monash Health,
246 Clayton Road, Clayton VIC 3168

Country

Australia

Phone

+61 3 9594 3959

Fax

[email protected]

Contact person for scientific queries

Name

Mayu Balachandran

Address

Monash Health,
246 Clayton Road, Clayton VIC 3168

Country

Australia

Phone

+61 3 9594 3959

Fax

[email protected]

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:
Dr Mayu Balachandran
[email protected]

Principal Investigator:
Prof Yahya Shehabi
[email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
24183	Statistical analysis plan					378383-(Uploaded-10-09-2024-18-30-46)-ALBICS-AKI SAP 29Aug2024.docx
24196	Statistical analysis plan				29/08/2024	378383-(Uploaded-16-09-2024-18-38-05)-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

Source	Title	Year of Publication	DOI
Embase	Postoperative 20% albumin vs standard care and acute kidney injury after high-risk cardiac surgery (ALBICS): study protocol for a randomised trial.	2021	https://dx.doi.org/10.1186/s13063-021-05519-8

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically