PREVENTion With Sglt-2 Inhibition of Acute Kidney Injury in Intensive Care

• Status: Not yet recruiting
• Trial end date: 2027-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The George Institute
• Collaborator: University Medical Center Groningen
• Treatments: Sodium-Glucose Transporter 2 Inhibitors

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

• Requiring renal replacement therapy for intoxication

• 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