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Dapagliflozin in patients with critical illness: rationale and design of the DEFENDER study
Caio de Assis Moura Tavares1, Luciano César Pontes de Azevedo1, Álvaro Rea-Neto2
1Hospital Israelita Albert Einstein - São Paulo (SP), Brazil.
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.
Insights
The DEFENDER trial investigates dapagliflozin for critically ill patients with acute organ dysfunction. This study will assess if sodium-glucose cotransporter-2 inhibitors improve outcomes in intensive care unit settings.
Area of Science:
- Critical care medicine
- Pharmacology
- Nephrology
Background:
- Critical illness presents a significant global health challenge with high mortality.
- Sodium-glucose cotransporter-2 inhibitors demonstrate established cardiovascular and renal benefits.
- Limited research exists on the impact of SGLT2 inhibitors during acute illness.
Purpose of the Study:
- To evaluate the efficacy and safety of dapagliflozin in critically ill patients.
- To investigate the role of SGLT2 inhibitors in acute organ dysfunction within the ICU.
Main Methods:
- The DEFENDER trial is a randomized, open-label study involving 500 adult ICU patients.
- Participants receive either dapagliflozin (10mg) plus standard care or standard care alone for up to 14 days.
- The primary outcome is a composite of hospital mortality, need for kidney replacement therapy, and ICU length of stay within 28 days.
Main Results:
- This section is not yet available as the study is ongoing.
Conclusions:
- DEFENDER is the first trial of its kind, examining SGLT2 inhibitors in general ICU patients with acute organ dysfunction.
- The study is expected to yield crucial data on the utility of this drug class in critical care.
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