跳至主要内容
临床试验/ISRCTN64637517
ISRCTN64637517已完成不适用

Randomised double-blind placebo-controlled trial of 40 mg/day of Atorvastatin on reduction in severity of SEPSIS in ward patients

Heart of England Foundation Trust (UK)0 个研究点目标入组 414 人开始时间: 2007年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
414

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Aged more than 18 years
  • 2. Patients history suggestive of a new infection such as pneumonia, empyema, Urinary Tract Infection (UTI), meningitis, skin/soft tissue inflammation, acute abdominal infection, bone/joint infection, wound infection, catheter or device infection or endocarditis
  • 3. More than or equal to two of the following signs and symptoms of infection both present and new to the patient including:
  • a. temperature more than 38°C or 36°C
  • b. chills with rigors
  • c. heart rate more than 90 beats per minute
  • d. respiratory rate more than 20 bpm, or
  • e. headache with stiff neck

排除标准

  • 1. Signs of severe sepsis
  • 2. Known active liver disease, alcohol abuse or persistantly abnormal liver function tests
  • 3. Alanine aminotransferase more than two times the upper limit of normal laboratory ranges
  • 4. Creatine kinase more than three times the upper limit of laboratory normal ranges
  • 5. Pregnancy, breast feeding or women of child bearing potential not using adequate contraception
  • 6. Previous adverse reaction to statins
  • 7. Concomitant use of fibrates or other lipid lowering therapy
  • 8. Administration of Atorvastatin was ceased less than or equal to two weeks prior to the trial
  • 9. Concomitant use of erythromycin, telithromycin, clarithromycin, itraconazole, imidazoles, triazoles, cyclosporin or grapefruit juice
  • 10. Patients in another clinical trial
  • 11. Patients with terminal cancer
  • 12. Known ileus
  • 13. Failure to obtain written consent
  • 14. Inability to swallow tablets safely

研究者

发起方
Heart of England Foundation Trust (UK)

相似试验