Infusion of Methylene Blue in Severe Sepsis and Septic Shock: Randomized, Single Blinded
试验速览
- 阶段
- 3 期
- 入组人数
- 354
- 试验地点
- 3
- 主要终点
- 28 day mortality
研究概览
简要总结
This study is to see whether the intravenous administration of methylene blue improves the outcome in severe sepsis and septic shock.
详细描述
The mortality of septic shock is still high ranging from 30 to 50%. Vasopressor is the main part in managing septic shock, but the choice of vasopressor is still under-investigated, and area of uncertainty.
The response to vasopressor is sometimes unsatisfactory, and in that case, the outcome of the patients is poor.
Recently, small size clinical trial has investigated the effect of methylene blue (MB), and showed promising results. However, large sized phase III trial has not been performed yet.
Large sized phase III clinical trial is needed to establish the effect of MB in septic shock.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Septic shock meeting the criteria of 2012 surviving sepsis campaign
- •Need the norepinephrine of over 0.2microgram/kg/min
排除标准
- •Pregnancy
- •Less than 18 years old
- •Terminal cancer patients
- •Declined consents
- •glucose-6-phosphate dehydrogenase deficiency
- •Medication of Serotonin modulator
研究组 & 干预措施
Intravenous methylene blue administration
2mg/kg IV bolus followed by 0.5mg/kg/hr slow infusion for 6hrs
干预措施: Intravenous methylene blue administration (Drug)
Placebo
Normal saline administration instead of methylene blue
干预措施: Placebo (Drug)
结局指标
主要结局
28 day mortality
时间窗: within 28 days of diagnosis
次要结局
- NO level(before and after infusion of MB, 24hrs, 48hrs later)
- Vasopressor dependent period(within 28 days of diagnosis)
- Vasopressor index(with in 28 days of diagnosis)
- Change of cardiac output (CO) and systemic vascular resistance (SVR)(with in 28 days of diagnosis)
- Length of stay in ICU (LOSICU)(with in 28 days of diagnosis)
- LOS in hospital(with in 28 days of diagnosis)
- In hospital mortality(with in 28 days of diagnosis)
- Multiple organ failure (SOFA)(with in 28 days of diagnosis)
- Cytokine level (IL-6, 10, tumor necrosis factor -alpha)(before and after infusion of MB, 24hrs, 48hrs later)