A pilot trial of Dapagliflozin in patients at risk of acute kidney injury who are admitted to the intensive care unit

Phase 2

Recruiting

• Conditions: Diabetes; Acute kidney injury; Metabolic and Endocrine - Diabetes; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12623000940673
• Lead Sponsor: Prof Rinaldo Bellomo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-31
• Last Update Posted: 29 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified