Thymosin Alpha 1 in the Prevention of Pancreatic Infection Following Acute Necrotizing Pancreatitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 508
- 试验地点
- 2
- 主要终点
- Occurrence of pancreatic infection:
研究概览
简要总结
Infected pancreatic necrosis and its related septic complications are the major cause of death in patients with acute pancreatitis, therefore prevention of pancreatic infection is of great clinical value in the treatment of AP.
Immunosuppression and disorders characterized by decreased HLA-DR expression and unbalanced CD3/CD4+/CD8+ T cells of PBMC are thought to be associated with the development of pancreatic infection. Thymosin alpha 1 has been shown to have immunomodulatory properties and its effects in preventing pancreatic infection was not well studied. To evaluate the effects of TA1 use in the early phase on preventing pancreatic infection, immunomodulation and clinical outcomes in patients with AP,we aimed to design this study.
详细描述
Study Background & Rationale:
Infected pancreatic necrosis and its related septic complications are the major cause of death in patients with acute pancreatitis1, therefore prevention of pancreatic infection is of great clinical value in the treatment of AP.
Immunosuppression and disorders characterized by decreased HLA-DR expression and unbalanced CD3/CD4+/CD8+ T cells of PBMC are thought to be associated with the development of pancreatic infection2, 3. Thymosin alpha 1 has been shown to have immunomodulatory properties and its effects in preventing pancreatic infection was not well studied4.
Aim of This Study:
To evaluate the effects of TA1 use in the early phase on preventing pancreatic infection, immunomodulation and clinical outcomes in patients with AP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Thymosin
Thymosin alpha 1 has been shown to have immunomodulatory properties
干预措施: Thymosin Alpha 1 (Drug)
Placebo
normal saline;
干预措施: normal saline (Drug)
结局指标
主要结局
Occurrence of pancreatic infection:
时间窗: during the index admission
次要结局
- Incidence of pancreatic fistula(during the index admission)
- In-hospital mortality(during the index admission)
- Bleeding requiring intervention(during the index admission)
- The requirement for minimally-invasive debridement/Number of minimally invasive necrosectomy required(during the index admission)
- Mortality within 90 days after enrollment(90 days after enrollment)
- The occurrence of new-onset organ failure and new-onset persistent organ failure(during the index admission)
- Gastrointestinal perforation or fistula requiring intervention(during the index admission)
- The requirement for catheter drainage/Number of drainage procedures required(during the index admission)
- The requirement for open surgery/Number of open surgery required(during the index admission)
- New receipt of mechanical ventilation/renal replacement therapy /New receipt of vasoactive agents(during the index admission)
- Length of intensive care unit(ICU) stay/Length of hospital stay(during the index admission)
- SOFA score/ CRP level/ HLA-DR level/ Lymphocyte count(on day0, day7, and day14)
- In-hospital cost.(during the index admission)
- Incidence of infection within 90 days after enrollment(90 days after enrollment)
研究者
Weiqin Li
Professor
Nanjing University School of Medicine