跳至主要内容
临床试验/NCT00450840
NCT00450840Unknown4 期

Simvastatin in Patients With Septic Shock

Medical University of Vienna1 个研究点 分布在 1 个国家开始时间: 2007年3月22日最近更新:
适应症
相关药物

试验速览

阶段
4 期
试验地点
1
主要终点
Time to shock reversal as defined by cessation of vasopressor support > 1 hour

研究概览

简要总结

The beneficial effect of statins to prevent cardiovascular events in patients at risk is well established. Recent trials demonstrated that statins can exert a number of vascular actions independent of lipid lowering. Short-term simvastatin therapy recently has been reported to reduce mortality in 2 different animal models of sepsis. Pleiner and coworkers could demonstrate potent vasoprotective properties of simvastatin during Escherichia coli endotoxin induced endotoxemia in healthy volunteers. In a population-based cohort analysis it was demonstrated that administration of statins was associated with a reduced risk of subsequent sepsis. Thus, simvastatin treatment may offer a new therapeutic strategy for clinical conditions associated with inflammation like severe sepsis and septic shock. The aim of the present study is to test the hypothesis that short term treatment with simvastatin may mitigate the detrimental vascular effects of acute inflammation in patients admitted to the intensive care unit requiring treatment for 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
Double

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

  • •Age > 18 years
  • •Septic Shock for less than 48 hours

排除标准

  • •Pregnancy
  • •Unable to receive enteral medications
  • •Expected survival of less than 72 hours
  • •Treatment in the previous 3 weeks with simvastatin or other HMG-CoA reductase inhibitors
  • •History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
  • •History of known or suspected porphyria
  • •High risk of rhabdomyolysis (multiple trauma, crush injuries, extensive burns, baseline creatinine kinase (CK) ≥ten-times upper limit of normal
  • •Hemorrhagic shock

结局指标

主要结局

Time to shock reversal as defined by cessation of vasopressor support > 1 hour

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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