Simultaneously Using Traditional Chinese Medicine (Si-Ni-Tang) to Treat Septic Shock Patients - a Double Blind, Prospective, Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- time to cessation of vasopressor use
研究概览
简要总结
The purpose of this study is to determine whether simultaneously using the traditional Chinese medicine, Si-Ni-Tang, is more effective in the treatment of septic shock patients.
详细描述
Those with hemodynamic instability were the main population of the ICU patients, whether the exact etiology leading to the diseases. However, how to maintain adequate hemodynamic status in order to keep the patients with well organs perfusion is the main issue of the intensive care physicians. The choices of vasoactive drugs in the guidelines or experts' suggestions nowadays used are still limited in the western medicine. Si-Ni-Tang, a remedy previously used in ancient China and now widely prescribed in Taiwan and China, is used for treating patients diagnosed as shock or heart failure. The investigators are eager to know if there existed any benefit via adding this drug to treat the septic shock patients. Therefore, the investigators designed a prospectively randomized double blind control trial to determine whether simultaneously using the traditional Chinese medicine, Si-Ni-Tang, is more effective in the treatment of septic shock 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients admitted to our intensive care units are enrolled if their disease diagnosis meets the definition of septic shock
- •Using vasopressor now and the duration from initiation of vasopressor use to the entrance of the study is within 24 hours
- •Nasogastric tube feeding
排除标准
- •More than one kind of vasopressor is administrated
- •Patients with extremely poor gastrointestinal function and can not tolerate diet feeding
- •Acute myocardial infarction
- •Patients with evidence of major bleeding
- •Expected surgical intervention or scheduled surgery in the subsequent one week
- •Patients who received digoxin for arrhythmia in the past one week
研究组 & 干预措施
Si-Ni-Tang
干预措施: Si-Ni-Tang/ Placebo of Si-Ni-Tang (Drug)
Placebo
干预措施: Si-Ni-Tang/ Placebo of Si-Ni-Tang (Drug)
结局指标
主要结局
time to cessation of vasopressor use
时间窗: one week
次要结局
- intensive care unit (ICU) mortality(one month)
- ICU length of stay(one month)
- 28-day survival rate(one month)
研究者
Huang-Chi Chen
Attending Physician of the Internal Medicine Department, Changhua Christian Hospital
Changhua Christian Hospital