SimSepT: Simvastatin and severe sepsis in the ICU - SimSepT

Oxford Radcliffe Hospitals NHS Trust0 个研究点目标入组 200 人开始时间: 2005年10月4日最近更新: 2020年7月27日

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•Patients eligible for inclusion will be those admitted to an Adult Intensive Care Unit, with a known or suspected infection on the basis of clinical data at the time of screening and signs of severe sepsis (appendix 1a and 1b) or those who develop severe sepsis whilst in intensive care. Patients must be randomised within 24-hours of first recorded organ dysfunction to be included in the study. The first dose of SimSept trial drug (placebo or simvastatin) must be given within 24-hours of randomisation.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patients will be excluded from the trial if they:
•are receiving simvastatin or another statin prior to admission,
•refuse consent or their relatives refuse assent,
•are less than 16-years of age,
•are included in another interventional study,
•have a known adverse reaction to statins,
•have an indication or contraindication to treatment with a statin, according to the treating physician,
•are unable to receive enteral medications,
•are receiving drugs known to interact with simvastatin,
•have active liver disease,
•have severe renal impairment (anuria, creatinine >400µmol.l-1or requirement for renal replacement therapy despite adequate haemodynamic resuscitation),
•are at high risk of rhabdomyolysis (multiple trauma, crush injuries, extensive burns, baseline creatinine kinase (CK) = five-times upper limit of normal (ULN)),
•have a history of known or suspected porphyria,
•are unlikely to survive more than 24h,
•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