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

UW 23-609

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.

2024-09-01

2027-02-28

2027-02-28

Not yet recruiting

60

Inclusion Criteria: * 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 Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2024-06-25