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临床试验/NCT01193777
NCT01193777终止1 期

L-Carnitine Administration in Early Sepsis

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

干预措施: Normal Saline (Drug)

L-Carnitine

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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