Evaluation of the Efficacy of Anisodamine Hydrobromide Combined With Low-molecular-weight Heparin in the Treatment of Patients With Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 782
- 试验地点
- 1
- 主要终点
- 28-day mortality
研究概览
简要总结
The study aimed to investigate the effectiveness of anisodamine hydrobromide combined with heparin in the treatment of patients with critical infection, in the hope that the therapy will provide alternatives to the treatment of patients with critical infection.
详细描述
Objective
The study aimed to investigate the effectiveness of anisodamine hydrobromide combined with heparin in the treatment of patients with critical infection, in the hope that the therapy will provide alternatives to the treatment of patients with critical infection.
Methods: The study is a multi-center randomized controlled clinical trial. Study population will include critically infected patients requiring vasopressor use. The critically infected patients will be randomly assigned to four groups in a ratio of 1:1. The groups will consist of the conventional treatment group and the anisodamine hydrobromide combined with heparin treatment group.
Interim analysis will be performed. The primary study end point is 28-day mortality, and other secondary study endpoint is lactate clearance rate. The investigators will appropriately use chi-square test, student t test or rank sum test to compare the differences between the experimental groups and the control group.
Discussion: The treatment of anisodamine hydrobromide combined with heparin will be better than the conventional treatment. The study will provide new insight into the treatment of patients with critical infection and can help to reduce mortality rate of critically infected patients.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 110 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
Anisodamine hydrobromide combined with heparin
Anisodamine hydrobromide injection + low molecular weight heparin + basic treatment: The dosage of scopolamine butylbromide is 2.0mg/(kg*d), administered via a micro-pump at a constant rate, continuously for 3 days. The dosage range for low molecular weight heparin is limited to 3000-6000U, administered subcutaneously once daily, continuously for 3 days.
干预措施: Anisodamine hydrobromide combined with heparin (Drug)
结局指标
主要结局
28-day mortality
时间窗: Every patients' survival time will be observed on day 28 after admission.
The patients will be followed up for 28 days, as our usual hospital length of stay for critically infected patients is 28 days. The investigators will recorded the specific time of death.
次要结局
- Lactate clearance rate(The lactate clearance rate was observed at 6 hours, 24 hours, and 72 hours after admission.)
研究者
Chen Ying
Research assistant；Junior technician
Beijing Chao Yang Hospital