ACTRN12623000940673RecruitingPhase 2
Dapagliflozin in Patients at Risk of Acute Kidney Injury (AKI) Admitted to Intensive Care: A Pilot, Single-Centre, Efficacy, Feasibility, Safety, Randomised, Placebo-Controlled Trial
Prof Rinaldo Bellomo0 sites40 target enrollmentStarted: August 31, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
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
Investigators
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