Dapagliflozin in Patients With Critical Illness: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 507
- 试验地点
- 23
- 主要终点
- Win Ratio
研究概览
简要总结
To assess the effects of dapagliflozin on a composite hierarchical endpoint in critically ill patients.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to an intensive care unit with expected duration of admission of at least 48 hours in the opinion of the attending physician AND
- •Patients with at least one new organ dysfunction:
- •Hypotension (mean arteria pressure below 65 mmHg or systolic blood pressure below 90 mmHg or use of vasopressors - norepinephrine, epinephrine, adrenaline, or vasopressin at any dose);
- •Signs of acute kidney injury (increase in serum creatinine above 0.3 mg/dL over previous measurement or decrease in urinary output - below 0.5 mL/kg/h - in the past six hours;
- •Need for new use of high-flow nasal catheter or noninvasive ventilation or invasive ventilation.
排除标准
- •Pregnancy or age below 18 years;
- •Patient or legal representative refusal;
- •Patients with chronic kidney disease on dialysis;
- •Planned intensive care unit admission after elective surgery;
- •Known allergy to dapagliflozin;
- •Previous use of dapagliflozin or other sodium-glucose transport protein 2 inhibitor;
- •Patients that cannot receive medications through oral or enteral route;
- •Patients with inclusion criteria number 2 for more than 24 hours.
- •Patients with type 1 diabetes or previous ketoacidosis
研究组 & 干预措施
Standard of Care
Current standard of care for critically ill patients.
干预措施: Standard of Care (Other)
Standard of care plus dapagliflozin
Current standard of care for critically ill patients plus open-label dapagliflozin 10 mg per day for 14 days or until ICU discharge
干预措施: Dapagliflozin 10mg Tab (Drug)
结局指标
主要结局
Win Ratio
时间窗: 28 days
Hierarchical endpoint of hospital mortality, use of kidney replacement therapy and intensive care unit length-of-stay
次要结局
- Hospital Mortality(28 days)
- Use of kidney replacement therapy(28 days)
- Intensive Care Unit Free Days(28 days)
- Hospital Free Days(28 days)
- Vasopressor Free Days(28 days)
- Mechanical Ventilation Free Days(28 days)
- Kidney Replacement Therapy Free Days(28 days)