None listed
Conditions
Brief summary
Over the last few years, evidence has emerged that Dapagliflozin, a blood sugar lowering drug that can be administered as a tablet, does not just return blood sugar levels toward normal with minimal or no side effects but also protects the kidney form injury. This drug has also been shown to slow the progression of heart and kidney related complications of diabetes and heart failure patients. This makes treatment with Dapagliflozin potentially desirable in patients at risk of acute kidney injury who are admitted to the intensive care unit. However, the effect of Dapagliflozin in such patients, although logical, has not yet been studied. For this reason, we are planning to perform a clinical research project, known as a randomised controlled trial. We aim to evaluate whether giving oral Dapagliflozin (10mg daily for up to 28-days while in ICU) compared to placebo (a dummy tablet) in ICU patients at risk of acute kidney injury (AKI) decreases the severity and risk of injury and maintains blood sugar levels while decreasing the use of insulin. We plan to study 40 patients at high risk of developing AKI. If our findings demonstrate safety and potential benefit, they will allow this treatment to be studied in larger groups and, perhaps become a new effective treatment for these patients.
Interventions
Dapagliflozin 10 milligram tablet, administered orally, once daily, from the day of enrolment for a maximum of 28 days while the patient is admitted to the intensive care with adherence monitored via medical record audit.
Sponsors
Prof Rinaldo Bellomo
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult aged 18 years or older Admitted to the intensive care unit within the last 7 days Expected to remain in intensive care until the day after tomorrow Arterial or central venous catheter access in situ or planned Central venous catheter access in situ or planned Able to receive study treatment via the enteral route At least one risk factor for AKI as defined below: Pre-existing diagnosis of Type 2 Diabetes Mellitus (T2DM) At least one of these two risk factors for Acute Kidney Injury (AKI): - Required fluid resuscitation, defined as a bolus of fluid prescribed to be given over less than 1 hour to increase or maintain intravascular volume, in addition to maintenance fluids - Being treated with continuous vasopressors or inotropes to maintain a systolic blood pressure (SBP) < 90 mmHg, or mean arterial blood pressure (MAP) > 60 mmHg or a MAP target set by the treating clinician to maintain perfusion At least one of the following pre-morbid risk factors: - Treatment for high blood pressure - Treatment for Type 2 diabetes (minimum diet therapy) - History of coronary artery disease - History of heart failure - Impaired renal function, defined as an estimated Glomerular Filtration rate (eGFR) of 60 ml/min/1.73m2 or greater - Estimated body mass index (BMI) 30 kg/m2 or more - Age 60 years or older
Exclusion criteria
Met all inclusion criteria >24 hours ago History of Type-1 diabetes mellitus (T1DM) Requiring renal replacement therapy for intoxication Admission with urosepsis eGFR less than 20 ml/min/1.73m2 at the time of assessment for enrolment Known hypersensitivity to any SGLT2 inhibitor medication (dapagliflozin, canagliflozin, empagliflozin) Solid organ transplantation with the last 12 months Likely to be transferred to another hospital in the next 3 days Known or suspected pregnancy Death is deemed imminent or inevitable Life expectancy is estimated to be less than 90 days Patient or the treating clinician declines to participate Enrolled in another interventional trial for which co-enrolment is not approved Patient has previously been enrolled in the PREVENTS-AKI study
Outcome results
None listed