NCT05558098

Dapagliflozin in Patients With Critical Illness

Dapagliflozin in Patients With Critical Illness: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 507 (actual)
• Sponsor: Hospital Israelita Albert Einstein · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the effects of dapagliflozin on a composite hierarchical endpoint in critically ill patients.

Detailed description

Critically ill patients in the intensive care unit (ICU) experience a high mortality rate. Recent data indicates that the mortality rate for unplanned ICU admissions exceeds 30%, highlighting the urgent need for therapies that can reduce mortality in these critical patients. DEFENDER is an investigator-initiated, multi-center, randomized, open-label clinical trial, conducted in Brazilian ICUs. The study population will consist of participants who have been admitted to an ICU with an expected length of stay of more than 48 hours with evidence of at least an acute organ dysfunction, such as hypotension, signs of acute kidney injury, and/or the need for new use of high-flow nasal catheter, noninvasive or invasive ventilation. Eligible patients will be enrolled within 24 hours after the onset of organ dysfunction. Participants will be randomly assigned in a 1:1 ratio to receive either dapagliflozin 10mg (for 14 days or until ICU discharge, whichever occurs sooner) in addition to standard of care, or standard care alone. The primary outcome of the study is a hierarchical composite endpoint, including: i) hospital mortality, ii) initiation of kidney-replacement therapy, and iii) ICU length of stay. These outcomes will be assessed up to 28 days after randomization, with censoring at the time of hospital discharge. To ensure participant safety, an independent Data and Safety Monitoring Board will periodically review the data.

Conditions

• Critical Illness
• Sepsis

Interventions

Type	Name	Description
DRUG	Dapagliflozin 10mg Tab	Dapagliflozin 10 mg once per day for 14 days or until intensive care unit discharge or death
OTHER	Standard of Care	Current standard of care for management of critically ill patients

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-10-20
• Completion: 2023-10-20
• First posted: 2022-09-28
• Last updated: 2023-10-31

Locations

23 sites across 1 country: Brazil