RCT: Dapagliflozin Does Not Improve Outcomes in Critically Ill Patients With Acute Organ Dysfunction – JAMA

Study Design and Population: This multicenter, open-label, randomized clinical trial conducted across 22 ICUs in Brazil evaluated the effect of adding dapagliflozin to standard care in 507 critically ill patients with at least one acute organ dysfunction (respiratory, cardiovascular, or kidney). The study took place between November 2022 and September 2023, with participants randomly assigned to either 10 mg of dapagliflozin plus standard care or standard care alone for up to 14 days or until ICU discharge.

Main Findings: The primary outcome, a hierarchical composite of hospital mortality, initiation of kidney replacement therapy, and ICU length of stay, showed no significant difference between the dapagliflozin and control groups (win ratio, 1.01; 95% CI, 0.90 to 1.13; P = .89). Secondary outcomes also did not demonstrate significant benefits, although dapagliflozin had a slightly higher probability of reducing the need for kidney replacement therapy.

Implications for Practice: The addition of dapagliflozin to standard care in critically ill patients with acute organ dysfunction did not improve overall clinical outcomes. Although the study did not find significant benefits, the wide confidence intervals suggest that further research could be warranted to explore potential effects more definitively.

Reference: Tavares, C. A. M., Azevedo, L. C. P., Rea-Neto, Á., et al. (2024). Dapagliflozin for Critically Ill Patients With Acute Organ Dysfunction: The DEFENDER Randomized Clinical Trial. JAMA, 332(5), 401-411. DOI: 10.1001/jama.2024.10510.