Background The incidence of cardiac surgery associated acute kidney injury (CS-AKI) remains high. Patients who develop AKI after cardiac surgery are at higher risk of persistent renal dysfunction and increased long-term mortality. The risk of CS-AKI is significantly increased in patients with chronic kidney disease and in patients having prolonged bypass for complex surgery. Previous trials of albumin did not show any benefit in prevention of CS-AKI. These trials, however, did not focus on high-risk patients and used albumin as a resuscitation strategy. The aim of ALBICS-AKI is to demonstrate the effect of concentrated albumin infusion on CS-AKI in high-risk patients undergoing cardiac surgery compared with standard care.

Methods ALBICS-AKI is an investigator initiated, multicentre, randomised, open label trial. Seven centres in Australia and Italy will participate in the trial. We will randomise 620 adult patients who will undergo on-pump cardiac surgery with one of the following: an estimated glomerular filtration rate <60 ml/min/1.73m2, combined valve/s, coronary artery, or surgery involving thoracic aorta. Within 6 hours after surgery, a 20% albumin infusion will commence at 20ml/h for 15 hours. All patients will receive standard care as per institutional protocols. The primary outcome is the proportion of patients with AKI according to creatinine based KDIGO definition at hospital discharge or day 28, whichever comes first. Secondary outcomes include Major Adverse Kidney Events at day 28, AKI stage II and III, need for renal replacement therapy, and hospital mortality.

Ethics and dissemination The trial was approved by Monash Health Lead Research Committee for Australian sites and by the Italian Medicine Agency for Italian sites. The estimated study completion date is Sep 2024. The results will be presented at major conferences and submitted for publication in peer-reviewed journals.

Trial registration number Australian New Zealand Clinical Trials Registry ACTRN12619001355167

The authors have declared no competing interest.

ACTRN12619001355167

https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05519-8

The ALBICS-AKI trial is primarily funded by institutional funds from the Department of Surgery, School of Clinical Sciences, Monash University. The Prince of Wales Hospital Foundation provided a small grant to support the trial onsite. The Commonwealth Serum Laboratory (CSL-Behring Australia) provided a small grant in 2021, in support of research support staff.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The ethics committee of Monash Health gave ethical approval for this work. The ethics committee of The Italian Medicines Agency gave ethical approval for this work.

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Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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ALBICS-AKI Investigators: Claire Harington, Lewis Raymond, Peter Grant – Prince of Wales, and Prince of Wales Private Hospital, Randwick, New South Wales. Lisa Dougherty – Cabrini Health, Malvern, Victoria. Akinori Maeda, Atthapong Phongphithakchai, Sofia Spano – Austin Hospital, Melbourne, Victoria. David Bleetman, Phoebe Darlison, Jennifer Holmes, Melissa King – St Vincent’s Hospital Melbourne, Fitzroy, Victoria. Joanne McIntyre – Department of ICU, Flinders Medical Centre, Bedford Park, South Australia; All in Australia. Vanessa Bottari and Francesco Albano – Careggi University Hospital, Florence, Italy.

Data sharing is not applicable to this article as no datasets were generated or analysed for the creation of this statistical analysis plan and updated protocol.

The datasets and statistical code for the completed study will be available according to Monash University data sharing protocols. The authors have no contractual agreements to disclose that would limit such access.