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PREVENTion With Sglt-2 Inhibition of Acute Kidney Injury in Intensive Care
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.
Study details:
Acute kidney injury (AKI) is an increasingly common complication of hospitalisation globally, and a major driver of poor patient outcomes, including higher mortality and reduced quality of life. While numerous studies, including several led by investigators in this grant team, have tested treatments to reduce the impact of AKI, none have been shown to improve outcomes. The absence of any proven therapy highlights a critical unmet need.
A novel class of medicines, inhibitors of the sodium-glucose co-transporter II (SGLT-2 inhibitors), have been shown in recent years to have dramatic effects upon cardiovascular and renal outcomes in patients with heart failure at high risk for renal failure. The evidence suggests that these drugs might prevent AKI from occurring, but this has not been intentionally tested in adequately powered trials. A recently published randomised controlled trial evaluated the use of these drugs in acutely unwell COVID-19 patients and did not raise any safety concern in this acute setting.
The trial also showed a numerically lower rate of AKI in those that received the SGLT-2 inhibitor dapagliflozin compared to placebo, but the trial was not sufficiently powered for this outcome. The PREVENTion with Sglt2 inhibition of Acute Kidney Injury in intensive care (PREVENTS-AKI) trial, will test the effect of dapagliflozin versus placebo upon patients' risk of developing severe AKI in a population admitted to intensive care. This global trial will test the most promising treatment for mitigating the increased risk of AKI.
The results will provide the first definitive insight into the prevention of AKI with these agents and will shape global clinical practice in an area where treatments are profoundly lacking.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-11-29
Primary completion: 2026-08-31
Study completion finish: 2027-03-01
Study type
PREVENTION
Phase
PHASE3
Trial ID
NCT05468203
Intervention or treatment
DRUG: Dapagliflozin 10mg Tab
DRUG: Placebo
Conditions
- • Acute Kidney Injury
Find a site
Closest Location:
Grampians Health
Research sites nearby
Select from list below to view details:
Grampians Health
Ballarat, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Dapagliflozin
| DRUG: Dapagliflozin 10mg Tab
|
PLACEBO_COMPARATOR: Matched Placebo
| DRUG: Placebo
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Composite outcome: Doubling of serum creatinine from baseline, initiation of renal replacement therapy or death | Proportion of patients experiencing a component of the composite outcome, defined as a doubling of serum creatinine from the study baseline value, initiation of RRT or death | Within 30 days of randomisation |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Doubling of Serum Creatinine | Proportion of patients with a doubling of serum creatinine from baseline value | Within 30 days of randomisation |
| Requirement of Renal Replacement Therapy (RRT) | Proportion of patients requiring RRT | Within 30 days of randomisation |
| All-cause mortality | Proportion of patients who have died from any cause | Within 30 days of randomisation |
| Vasoactive drug therapy | Proportion of patients who were treated with vasoactive drugs | Within 30 days of randomisation |
| Mechanical ventilation | Proportion of patients who required mechanical ventilation | Within 30 days of randomisation |
| Ventricular tachycardia or ventricular fibrillation | Proportion of patients who experienced ventricular tachycardia or ventricular fibrillation lasting at least 30 seconds whilst in intensive care | Within 30 days of randomisation |
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