Abstract / Summary
Objective: This preliminarily study aims to evaluate the short-term efficacy and safety of dapagliflozin on multi-organ functions in patients with sepsis. Methods: This single-center, prospective, randomized controlled clinical trial enrolled 136 patients with sepsis to the Intensive Care Unit of Northern Jiangsu People's Hospital between April and December 2025. The patients were randomly assigned to the intervention group and the control group. Both groups received standardized treatment for sepsis, and the intervention group was also administered with dapagliflozin at a dose of 10 mg for 5 days. Changes in the sequential organ failure assessment (SOFA) scores after the intervention served as the primary outcome. The secondary outcomes included left ventricular ejection fraction (LVEF), renal function indicators, and clinical prognosis. Results: There were no statistically significant differences in the baseline data and changes in SOFA scores before and after treatment between the two groups (50 patients per group, P>0.05). On the 5th day of treatment, the median LVEF was significantly higher in the intervention group [60.0% (55.0%, 62.5%)] than in the control group [55.0% (49.0%, 58.0%), P<0.001]. The 28-day all-cause mortality rate in the intervention group [26% (13/50)] was lower than in the control group [36% (18/50)], but the variance did not reach statistical significance (P=0.387). The incidences of adverse events were comparable between both groups. The intervention group showed higher distribution of urine ketone body grades (Z=-2.1, P=0.040), but ketoacidosis was not observed. Conclusions: The short-term treatment of sepsis patients with dapagliflozin did not significantly reduce the SOFA scores, but improved LVEF and showed a trend of reducing all-cause mortality at 28 days. The short-term treatment was safe.