PREVENTion with SGLT-2 inhibition of Acute Kidney Injury in intensive care (PREVENTS-AKI)

Background

Acute Kidney Injury (AKI) affects up to 1 in 2 patients treated in the ICU, and is associated with poorer survival, reductions in long term kidney function and greater cost of treatment. There are no treatments proven to reduce these impacts of AKI but there is a growing evidence base suggesting that inhibitors of the sodium-glucose transport protein 2 (SGLT-2 inhibitors) in the kidney tubule may protect against AKI.

SGLT-2 inhibitors were originally developed as a treatment for type 2 diabetes but have been proven in recent clinical trials to significantly improve outcomes for patients with heart disease and/or kidney impairment - with fewer patients progressing to dialysis, needing hospital care or dying. Later examination of these trials has also shown lower rates of AKI in participants receiving SGLT-2 treatment but, as these results were not the main outcome of the studies, these findings are not enough to change patient treatment.

Aim

To conduct a prospective, multi-centre, parallel group, double blinded, phase III randomised controlled trial to determine whether treatment with a SGLT2 inhibitor (dapagliflozin) compared to placebo decreases the incidence of a composite end point of severe AKI or death in high-risk patients in intensive care units

Research Methodology

3,000 patients at high risk of AKI in the intensive care unit (ICU) will be enrolled at approximately 45-50 study sites globally. Patients will be randomly assigned to receive either dapagliflozin 10 mg or placebo daily while in ICU for up to 30 days.

Current Status

Ethical approval in Australia has been granted and study drug (matched placebo) manufactured. Vanguard sites in Victoria will begin recruitment in 4Q 2023.