Simvastatin and severe Sepsis: a randomised controlled Trial

Oxford Radcliffe Hospitals NHS Trust (UK)0 个研究点目标入组 104 人开始时间: 2005年9月1日最近更新: 2017年7月3日

适应症

试验速览

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•Patients eligible for inclusion:
•1. Those admitted to the Adult Intensive Care Unit at John Radcliffe Hospital, Royal Sussex County Hospital and the Royal Berkshire Hospital (last two centres added 10/10/2007)
•2. Severe sepsis or develop severe sepsis whilst in intensive care
•Patients must be randomised and receive the first dose of simvastatin within 24 hours of first organ dysfunction to be included in the study.

•Patients will be excluded from the trial if they:
•1. Are receiving simvastatin or another statin prior to admission
•2. Refuse consent or their relatives refuse assent
•3. Are less than 16 years of age
•4. Are included in another interventional study
•5. Have a known adverse reaction to statins
•6. Have an indication or contraindication to treatment with a statin, according to the treating physician
•7. Are unable to receive enteral medications
•8. Are receiving drugs known to interact with simvastatin
•9. Have active liver disease
•10. Have severe renal impairment (anuria) (removed from protocol as of 10/10/2007: creatinine >400 µmol.l^-1 or requirement for renal replacement therapy despite adequate haemodynamic resuscitation)
•11. Are at high risk of rhabdomyolysis [multiple trauma, crush injuries, extensive burns, baseline creatinine kinase (CK) =five-times upper limit of normal (ULN)]
•12. Have a history of known or suspected porphyria
•13. Are unlikely to survive more than 24 hours
•14. Are unable to speak English (or whose relatives are unable to speak English) and a suitable interpreter cannot be found

发起方

Oxford Radcliffe Hospitals NHS Trust (UK)