ACTRN12621001102864
Recruiting
Phase 2
Dapagliflozin in Patients with Type-2 Diabetes Admitted to Intensive Care: A Pilot Single-Centre, Feasibility Randomised Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- Austin Health
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult aged 18 years or greater
- •Expected to be admitted to the ICU until the day after tomorrow
- •Pre\-existing diagnosis of Type\-2 diabetes mellitus
- •Estimated Glomerular Filtration rate (eGFR) of less than 45 ml/min/1\.73m2
- •Able to take medication enterically
Exclusion Criteria
- •Diagnosis of Type\-1 diabetes mellitus (T1DM)
- •Documented SGLT2 inhibitor intolerance
- •Hepatic impairment with aspartate transaminase \[AST] or alanine transaminase \[ALT] greater than 3x the upper limit of normal \[ULN]; or total bilirubin greater than 2x ULN at time of enrolment
- •No enteric route for medication administration
- •Death is deemed to be imminent or inevitable during this admission
- •Patients with diabetic ketoacidosis
- •Pre\-existing urinary tract infection
- •Hypernatraemia defined as a serum sodium levels equal to or greater than 150 mmol/L at the time of screening
- •Clinician deems enrolment in the study is not in the patient’s best interests
Outcomes
Primary Outcomes
Not specified
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