NCT01070810已完成1 期
Thiamine as a Metabolic Resuscitator in Septic Shock
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Lactate Level 24 Hours After the First Study Medication Dose
研究概览
简要总结
The major goal of this project is to determine whether the use of thiamine in patients with septic shock will result in attenuation of lactic acidosis and a more rapid reversal of 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
- Triple (Participant, Care Provider, Investigator)
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
- •Greater than 18 years old
- •Suspected or confirmed source of infection
- •Hypotension (systolic pressure <90 mmHg) after a minimum 2 liter fluid bolus followed by vasopressor-dependence.
- •Lactic Acidosis > 3 mmol/dl
排除标准
- •Competing cause of lactic acidosis including: seizures within 3 hours of enrollment, use of linazolid metformin or anti-retrovirals at the time of enrollment, carbon monoxide or cyanide poisoning, highly suspected or known ischemic bowel, and known mitochondrial disorders
- •Liver dysfunction specifically defined as AST or ALT elevation greater than 240
- •Current Thiamine supplements or usage
- •Competing indication for thiamine administration
- •Cardiac Arrest
- •DNR/DNI or comfort care status (DNR status in an intubated patient receiving full care is eligible)
研究组 & 干预措施
1
Placebo Comparator
50 ml D5W
干预措施: D5W (Drug)
2
Experimental
200mg Thiamine in 50ml D5W
干预措施: Thiamine (Drug)
结局指标
主要结局
Lactate Level 24 Hours After the First Study Medication Dose
时间窗: 24 hours
次要结局
- APACHE II Score at 24 Hours(24 hours)
- Number of Participants With Shock Reversal(Hospital stay, average 2 weeks)
研究者
Michael Donnino
Michael W. Donnino, MD
Beth Israel Deaconess Medical Center
研究点 (1)
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