Artigo Acesso aberto Produção Nacional

Dapagliflozin in patients with critical illness: rationale and design of the DEFENDER study

2023; Volume: 35; Issue: 3 Linguagem: Inglês

10.5935/2965-2774.20230129-en

ISSN

2965-2774

Autores

Caio de Assis Moura Tavares, Luciano César Pontes Azevedo, Álvaro Réa-Neto, Niklas Söderberg Campos, Cristina Prata Amêndola, Ricardo Reinaldo Bergo, Amanda Christina Kozesinski-Nakatani, Paula Geraldes David-João, Glauco Adrieno Westphal, Mário Roberto Rezende Guimarães Júnior, Suzana Margareth Lobo, Marcos Soares Tavares, Marianna Deway Andrade Dracoulakis, Guilherme Martins de Souza, Guacyra Margarita Batista de Almeida, Otávio Gebara, Pablo Oscar Tomba, Camila Santos N Albuquerque, Mariana Castaldi Ramalho Silva, Adriano José Pereira, Lucas Petri Damiani, Thiago Domingos Corrêa, Ary Serpa Neto, Otávio Berwanger, Fernando G. Zampieri,

Tópico(s)

Neuroendocrine Tumor Research Advances

Resumo

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.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.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.NCT05558098.

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