Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-24 @ 7:14 PM
NCT ID:
NCT05468203
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05468203
Study Brief:
Protocol Section:
NCT05468203