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

What this Trial Is About

Sepsis is a serious global health issue causing millions of cases and high mortality, especially when organ failure leads to intensive care admission. This research investigates how SGLT2 inhibitors, a class of drugs originally for type 2 diabetes but shown to improve heart and kidney health, may affect clinical outcomes in adults with sepsis. The study aims primarily to assess the safety and effectiveness of these drugs in sepsis patients and secondarily to study their impact on inflammation markers. Adults aged 18 and older with new onset sepsis admitted to intensive care units will be randomly assigned to receive either the SGLT2 inhibitor empagliflozin 10 mg once daily or a placebo tablet daily, alongside standard care until hospital discharge. The trial is double-blind and placebo-controlled, designed to test both clinical outcomes and the feasibility of a larger multicenter study. Participants will be monitored daily during their hospital stay, with blood samples taken to measure inflammatory markers such as interleukins and C-reactive protein at baseline and day 7. Researchers will track primary outcomes including 28-day mortality and changes in organ failure scores, ensuring safety and efficacy data are collected throughout the trial. The study is expected to run until early 2027.

Efficacy of SGLT2 Inhibitors in Adults With Sepsis