A Randomized, Double-blind, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 4
- 主要终点
- 28 day mortality
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of early administration of two different doses of dexamethasone in high risk septic patients.
详细描述
The septic adult patients of high risk would be enrolled in 2 emergency departments.
Sepsis would be defined by Sepsis-3 definition. High risk is defined as initial systolic blood pressure less than 90 mmHg or blood lactate level over 2 mmol/L.
The enrolled patients would be randomized to 3 groups: control, low dose dexamethasone (0.1 mg/kg iv), and high dose dexamethasone (0.2mg/kg iv).
The study drug is blinded and administered after enrollment for 2 days. Sample size would be 102, considering 10% of drop-out rate, allocating 30 patients to each groups.
Efficacy would be evaluated as follows; 28 day and 90 day mortality, time to septic shock, time to shock reversal, administration of steroid according to guideline, ventilator free days, Continuous renal replacement, Length of stay in ICU or hospital, delta SOFA score on day 3 and day 7,
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sepsis defined by Sepsis-3 definition
- •Initial systolic blood pressure < 90mmHg or blood lactate level >2mmol/L
排除标准
- •advanced directive for "Do not resuscitation"
- •recent systemic administration of glucocorticoid (4 weeks)
- •recent systemic administration of chemotherapy (4 weeks)
- •recent systemic administration of immunosuppressant (4 weeks)
- •expected life less than 90 days
- •Transferred from other hospital
- •Sepsis diagnosed 24 hours after ED admission
- •Use of etomidate in ED
- •pregnant or on lactation
- •no informed consent
研究组 & 干预措施
low dose dexamethasone
0.1 mg/kg dexamethasone iv once per day, for 1 or 2 days
干预措施: Dexamethasone (Drug)
high dose dexamethasone
0.2 mg/kg dexamethasone iv once per day, for 1 or 2 days
干预措施: Dexamethasone (Drug)
结局指标
主要结局
28 day mortality
时间窗: 28 days
death at 28 day
次要结局
- Delta SOFA sore on day 3 and 7(7 days)
- Gastrointestinal bleeding(14 days)
- 90 day mortality(90 days)
- Administration of steroid according to guideline, yes or no(up to 1 month, During hospital stay)
- ventilator free days(up to 3 month, During hospital stay)
- Time to septic shock(up to 1 month, During hospital stay)
- Time to shock reversal(up to 1 month, During hospital stay)
- continuous renal replacement therapy (CRRT)(up to 3 month, During hospital stay)
- Hyperglycemia(7 days)
- Hypernatremia(7 days)
- Length of stay in intensive care unit (ICU)(up to 6 month, During hospital stay)
- Length of stay in hospital(up to 6 month, During hospital stay)
- Superinfection(28 days)
研究者
Kyuseok Kim
Professor, Emergency Department
CHA University