Efficacy of SGLT2 Inhibitors in Adults With Sepsis
Efficacy and Safety of Sodium-Glucose Cotransporter 2 Inhibitors in Adults With Sepsis: A Feasibility Study for a Multicenter Double-Blind Randomized Placebo-Controlled Trial
Hospital Authority, Hong Kong
60 participants
Mar 5, 2025
INTERVENTIONAL
Conditions
Summary
Goal of this clinical trial is to examine the safety and efficacy of SGLT2 inhibitors on the clinical outcomes in patients with sepsis. Main study outcomes are as follows: (i) Primary objective is to examine the efficacy and safety of SGLT2 inhibitors on clinical outcomes in patients with sepsis. (ii) Secondary objective is to examine the effect of SGLT2 inhibitors on inflammatory markers in patients with sepsis.
Eligibility
Inclusion Criteria5
- Aged 18 years or above
- New onset of sepsis within 48 hours defined according to the Sepsis-3 criteria. (≥2 SOFA)
- Provision of signed and dated informed consent form from participant or surrogate
- Ability to take and adhere to oral and enteral medication regimen
- Willingness to comply
Exclusion Criteria8
- Current or recent use of SGLT2 inhibitors (within 12wks prior to randomization)
- Impaired renal function
- Clinically unstable or in refractory hypotension
- History of ketoacidosis
- Gastrointestinal surgery or GI absorption / malabsorption disorder
- Pregnancy
- Known allergic or hypersensitivity reactions to any SGLT2 inhibitors
- Treatment with another investigational drug or other interventions within 30 days prior to trial
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Interventions
Empagliflozin 10mg once daily from recruitment to hospital discharge
Placebo single tablet once daily from recruitment to hospital discharge
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT06473844