ACTRN12607000028404已完成2 期
A phase II, randomised, placebo-controlled study of the safety, pharmacokinetics and effect on inflammatory marker levels of atorvastatin in intensive care patients with severe sepsis
Australia New Zealand Intensive Care Research Centre, a centre of Monash University0 个研究点目标入组 250 人开始时间: 2007年1月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 90 Years（—）
- 性别
- All
入选标准
- •All patients admitted to the intensive care unit with severe sepsis of less than 24 hours duration. Patients must have 3 or more features of systemic inflammatory response syndrome, a strongly suspected or confirmed site of sepsis, presence of organ dysfunction in at least one of the 5 following categories: (cardiovascular system , renal, respiratory, haematologic, unexplained metabolic acidosis).
排除标准
- •Death is imminent, pregnancy or breastfeeding, known history of intolerance to a statin agent, acute liver failure (INR[International Normalised Ratio] greater than 2.5), Child's C classification of liver disease ( a grade of C as measured on the Child-Pugh Classification of Liver Disease, ie very severe liver disease), ALT (alanine transaminase ) > 5 x ULN (Upper Limit of Normal), CK (creatinine kinase) > 5x ULN (Upper Limit of Normal), patient unable to take enteral medication, patient or next of kin/person responsible unable to provide informed consent, patient, family or physician not in favor of aggressive treatment.
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