Multicenter, Randomized, Controlled Study to Evaluate the Efficacy of Thymosin alpha1 in Patients With Severe Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 366
- 试验地点
- 1
- 主要终点
- 28-day Mortality
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of thymosin alpha 1 for treating severe sepsis.
详细描述
Severe sepsis is a disease of infectious origin with a high risk of death. Over the past decade, thymosin alpha1 have already provided clinicians with additional weapon in the fight against infectious diseases, but it is unknown whether thymosin alpha1 is effective in treating severe 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe sepsis according to ACCP/CCM criteria
- •Patient or legally authorized representative able to provide informed consent
排除标准
- •Subject is less than 18 years or more than 85 years of age
- •If female, the subject is pregnant or nursing
- •Subject is receiving immunosuppressive therapy such as cyclosporine, azothioprine,or cancer-related chemotherapy
- •Patient not expected to survive 28 days because of uncorrectable medical condition, such as poorly controlled neoplasm or other end-stage disease
- •History of bone marrow, lung, liver, pancreas, or small-bowel transplantation
- •Acute pancreatitis with no established source of infection
研究组 & 干预措施
Thymosin alpha 1+Standard Therapy
Patients receive treatment based on SSC guideline with additional thymosin alpha1
干预措施: Thymosin alpha 1 (Drug)
normal saline+standard therapy
Patients receive treatment based on SSC guideline with additional normal saline.
干预措施: Thymosin alpha 1 (Drug)
结局指标
主要结局
28-day Mortality
时间窗: 28 days
The prospectively defined primary end point was death from any cause and was assessed 28 days after the start of the infusion.
次要结局
- SOFA score(7 days)
- Immune response to Thymosin alpha 1(7 days)