1. Dapagliflozin in patients with critical illness: rationale and design of the DEFENDER study.
- Author
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Tavares CAM, Azevedo LCP, Rea-Neto Á, Campos NS, Amendola CP, Bergo RR, Kozesinski-Nakatani AC, David-João PG, Westphal GA, Guimarães Júnior MRR, Lobo SMA, Tavares MS, Dracoulakis MDA, Souza GM, Almeida GMB, Gebara OCE, Tomba PO, Albuquerque CSN, Silva MCR, Pereira AJ, Damiani LP, Corrêa TD, Serpa-Neto A, Berwanger O, and Zampieri FG
- Subjects
- Adult, Humans, Multiple Organ Failure drug therapy, Multicenter Studies as Topic, Critical Illness therapy, Sodium-Glucose Transporter 2 Inhibitors therapeutic use
- Abstract
Background: Critical illness is a major ongoing health care burden worldwide and is associated with high mortality rates. Sodium-glucose cotransporter-2 inhibitors have consistently shown benefits in cardiovascular and renal outcomes. The effects of sodium-glucose cotransporter-2 inhibitors in acute illness have not been properly investigated., Methods: DEFENDER is an investigator-initiated, multicenter, randomized, open-label trial designed to evaluate the efficacy and safety of dapagliflozin in 500 adult participants with acute organ dysfunction who are hospitalized in the intensive care unit. Eligible participants will be randomized 1:1 to receive dapagliflozin 10mg plus standard of care for up to 14 days or standard of care alone. The primary outcome is a hierarchical composite of hospital mortality, initiation of kidney replacement therapy, and intensive care unit length of stay, up to 28 days. Safety will be strictly monitored throughout the study., Conclusion: DEFENDER is the first study designed to investigate the use of a sodium-glucose cotransporter-2 inhibitor in general intensive care unit patients with acute organ dysfunction. It will provide relevant information on the use of drugs of this promising class in critically ill patients., Clinicaltrials.gov Registry: NCT05558098.
- Published
- 2023
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