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A single-site study of the effectiveness of Dapagliflozin for diabetic patients admitted to the intensive care unit

Phase 2
Recruiting
Conditions
Diabetes
Metabolic and Endocrine - Diabetes
Registration Number
ACTRN12621001102864
Lead Sponsor
Austin Health
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
40
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
Pregnancy
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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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