Using Dapagliflozin to Prevent Acute Kidney Injury in ICU Patients
PREVENTion With Sglt-2 Inhibition of Acute Kidney Injury in Intensive Care
This study is testing if the diabetes medication Dapagliflozin can help prevent kidney injuries in critically ill patients in the ICU.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The George Institute Academic / other |
| Locations | 2 sites (Ballarat, Victoria and 1 other locations) |
| Trial ID | NCT05468203 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Dapagliflozin, a medication typically used for diabetes and heart disease, in preventing acute kidney injury (AKI) in critically ill patients admitted to the Intensive Care Unit (ICU). Participants will receive either Dapagliflozin or a placebo to determine if the medication can reduce the incidence of severe AKI. The study is designed as a Phase 3 interventional trial and will involve patients who have specific risk factors for developing AKI. The trial seeks to address a significant unmet need in critical care, as current treatments for AKI have not proven effective.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been admitted to the ICU within the last week and have specific risk factors for AKI.
Not a fit: Patients who are not critically ill or do not have risk factors for acute kidney injury may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide a new preventive treatment option for critically ill patients at risk of acute kidney injury.
How similar studies have performed: While previous studies have suggested potential benefits of SGLT-2 inhibitors in related contexts, this specific approach in critically ill patients has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or more * Admitted to ICU within the last 7 days * Expected to be in the ICU the day after tomorrow * An arterial or central venous catheter is in situ, or placement is planned for routine management * Able to receive study treatment orally or via enteral route * At least one of the following risk factors for AKI: * Required fluid resuscitation, defined as a bolus of fluid prescribed to be given over ≤1 hour to increase or maintain intravascular volume that is in addition to maintenance fluids * Being treated with continuous vasopressors or inotropes to maintain a systolic blood pressure \> 90mmHg, or mean arterial blood pressure \> 60mmHg or a MAP target set by the treating clinician for maintaining perfusion * At least one of the following pre-morbid risk factors: * Treatment for high blood pressure * Treatment for type 2 diabetes (minimum diet therapy) * Atherosclerotic cardiovascular disease * History of heart failure * Impaired renal function, defined as an eGFR between 20 - 60 mL/min/1.73m2 * Estimated BMI 30 kg/m2 or more * Age 60 years or more Exclusion Criteria: * Met all inclusion criteria more than 24 hours ago * History of type 1 diabetes mellitus or diabetic ketoacidosis * COVID-19 infection as the reason for ICU admission * Requiring renal replacement therapy for intoxication * eGFR less than 20 mL/min/1.73m2 * Known hypersensitivity to any SGLT-2 inhibitor e.g. dapagliflozin, canagliflozin, empagliflozin, ertugliflozin * Solid organ transplantation within 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
Where this trial is running
Ballarat, Victoria and 1 other locations
- Grampians Health — Ballarat, Victoria, Australia (Not_yet_recruiting)
- Austin Health — Heidelberg, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Sarah Coggan, BSc, MPH
- Email: scoggan@georgeinstitute.org.au
- Phone: 02 9993 4566
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.