PREVENTion With Sglt-2 Inhibition of Acute Kidney Injury in Intensive Care
Status:
Not yet recruiting
Trial end date:
2027-07-01
Target enrollment:
Participant gender:
Summary
Background Acute Kidney Injury (AKI) is a potentially life-threatening condition caused by
unsafe levels of fluid and waste products accumulating in the body. Often, patients with AKI
need treatment with an artificial kidney (called renal replacement therapy or dialysis) to do
the work of their kidneys and remove these dangerous levels of fluid and waste from the body.
If left untreated, AKI can become a chronic (long-term) condition that may require treatment
for life.
Dapagliflozin is a medication used to treat patients with diabetes, heart disease and
long-term (chronic) kidney disease. Recently, Dapagliflozin has been shown to slow the
progression of other kidney related complications, however this has not yet been studied in
critically ill patients.
Aim To determine if giving Dapagliflozin (one tablet a day) compared to placebo (a tablet
that looks identical but has no active ingredients), decreases injury to the kidneys in
patients admitted to the Intensive Care Unit.
Design This study will enrol 3000 patients from 45-50 hospitals worldwide. It is a
'randomised controlled trial' meaning patients will be randomly assigned (like tossing a
coin) by a computer to receive either Dapagliflozin or placebo for a maximum of 30 days
whilst in the ICU. The study is also a 'double blinded trial' meaning that neither the
doctor, the intensive care staff or the patient will know which study treatment they are
receiving.