The Efficacy of Xuebijing Injection in Adult Patients With Sepsis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,817
- 试验地点
- 1
- 主要终点
- All-Cause Mortality
研究概览
简要总结
The Efficacy of Xuebijing Injection in Adult Patients with Sepsis
详细描述
The purpose of this placebo-controlled study is to determine if Xuebijing Injection treatment provides significant mortality reduction improvement in patients with sepsis compared with placebo treatment in patients receiving the current standard of care for sepsis. This study will also assess the effectiveness of Xuebijing Injection in reducing 28-day mortality in patients with sepsis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Blind (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be eligible for inclusion if all of the inclusion criteria are met
- •Sepsis-3 criteria from Society of Critical Care Medicine (SCCM) /European Society of Intensive Care Medicine (ESICM)
- •18≤ age ≤75years
- •2 ≤SOFA ≤13
- •obtain informed consent
排除标准
- •Diagnosis of sepsis for more than 48 h;
- •Pregnant and lactating women;
- •Severe primary disease including unrespectable tumours, blood diseases and Human Immunodeficiency Virus (HIV);
- •Severe liver and kidney dysfunction (single liver or kidney SOFA score ≥ 3 points);
- •Use of an immunosuppressant or having an organ transplant within the previous 6 months;
- •Participating in other clinical trials in the previous 30 days.
研究组 & 干预措施
Intervention Group
100ml Xuebijing Injection will be dissolved in 100 mL of normal saline every 12 hours for 5 days in blind fashion.
干预措施: Xuebijing Injection (Drug)
Placebo group
normal saline 200 mL every 12 hours for 5 days
干预措施: normal saline (Drug)
结局指标
主要结局
All-Cause Mortality
时间窗: 28 Days after randomization
Death from all causes at 28-days
次要结局
- SOFA score(Day 0,3,6 after randomization)
- Percentage of Human Leukocyte Antigen-DR(0，6 days after randomization)
- ICU stay(28 days after randomization)
- Death in ICU(28 Days after randomization)
- Duration of mechanical ventilation(28 days after randomization)
- Concentration of C-reactive protein(0,3,6days after randomization)
- APACHEⅡ(Day 0,3,6 after randomization)
- Concentration of Procalcitonin(0,3,6 days after randomization)
研究者
Songqiao Liu
Principle investigator
Southeast University, China