L-Carnitine Administration in Early Sepsis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Reduction in organ failure
研究概览
简要总结
Sepsis is a severe and overwhelming response to an infection in the body. Over 750,000 patients in the United States develop sepsis every year. As sepsis becomes progressively more severe, a patient's blood pressure drops to dangerous levels and the body cannot pump oxygen to the rest of the body, which is necessary for normal cell function. This is called septic shock. When someone develops septic shock, it is very common for the smallest blood vessels in the body called the microcirculation to clog, like a highway during rush hour. Even with the best medical care, more than one in three patients with septic shock will die.
The major goal of this study is to test if intravenous replacement of a naturally occurring nutrient that is lost by the body during sepsis called L-carnitine can reduce how sick a patient with sepsis becomes. In our study, some patients will receive L-carnitine and others will receive saline. We will measure markers determining severity of illness in both groups and compare them to see if L-carnitine helps patients get better faster. Based on research already conducted, we believe L-carnitine will improve blood flow in the microcirculation, delivering more oxygen to cells, and help the body get better. To test if this is true, we will directly look at the microcirculation under the tongue with a special magnifying camera that looks at red blood cells, and compare both groups.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Suspected or confirmed infection
- •Any two of four criteria of systemic inflammatory response
- •Requirement for vasopressors to treat shock
- •Enrollment within 12 hours of vasopressor initiation
- •SOFA score of greater than or equal to 5 at the time of enrollment
排除标准
- •Age <18 years
- •Pregnancy or breastfeeding
- •Any primary diagnosis other than sepsis
- •Established Do Not Resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable
- •Any history of seizures or a known seizure disorder
- •Any known inborn error of metabolism
- •Anticipated requirement for surgery that would interfere with the 12 hour infusion time
- •Active participation in another interventional study
- •Inability to obtain informed consent
- •Cardiopulmonary resuscitation (chest compression or defibrillation) prior to enrollment
- •Known systemic allergy to carnitine
研究组 & 干预措施
Saline
干预措施: Normal Saline (Drug)
L-Carnitine
干预措施: L-Carnitine (Drug)
结局指标
主要结局
Reduction in organ failure
时间窗: 24 hours
SOFA score will be measured at 0 and 24 hours
次要结局
- Microcirculation(12 hours)
- All-cause mortality(12 months)
- ICU and hospital length of stay(Duration of stay)
- Change in inflammatory markers(48 hours)
