NCT02936232招募中不适用
Severe Sepsis and Septic Shock Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 3
- 主要终点
- 28-day mortality
研究概览
简要总结
The aim of this study is to construct multi-center sepsis registry that can be used for data warehousing and clinical research.
详细描述
This registry prospectively enrolls adult patients with severe sepsis or septic shock in 21 tertiary hospital emergency departments.
Registered data can be used for quality control and clinical research to reduce sepsis-related mortality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •two of more systemic inflammatory reaction syndrome criteria fever > 38.3 'C or hypothermia < 36'C, tachycardia over 90 bpm tachypnea over 20 per minute, leukocytosis (WBC over 12k/microL) or leukopenia (WBC below 4k/microL)
- •suspected or proven infection
- •any organ dysfunction as follows:
- •cardiovascular (hypotension, systolic blood pressure <90 mmHg, mean arterial pressure <70mmHg)
- •tissue hypoperfusion (lactate above upper limits laboratory normal)
- •acute lung injury (PaO2/inspired oxygen fraction < 250 in the absence of pneumonia, PaO2/inspired oxygen fraction < 200 in the presence of pneumonia)
- •acute kidney injury (Urine output < 0.5mL/kg/hr for at least 2 hrs Serum creatinine > 2.0 mg/dL)
- •acute liver injury (Total bilirubin > 2mg/dL)
- •acute coagulopathy (Platelet count < 100,000/μL or prothrombin time, international normalized ratio > 1.5)
排除标准
- •age less than 18 years old
- •patients with cardiac arrest at presentation
- •patients with advanced directives not to deliver aggressive organ supportive management
结局指标
主要结局
28-day mortality
时间窗: 28-day
According to hospital discharge record review and telephone follow-up.
次要结局
- ICU length of stay(hospital discharge (non-survivors) or 90 days (survivors))
- Organ support treatment (mechanical ventilation)(hospital discharge (non-survivors) or 90 days (survivors))
- Hospital length of stay(hospital discharge (non-survivors) or 90 days (survivors))
- 90-day mortality(90-day)
- Organ support treatment (renal replacement therapy)(hospital discharge (non-survivors) or 90 days (survivors))
研究者
Gil Joon Suh
Professor
Seoul National University Hospital
研究点 (3)
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