ACTRN12611000649910终止1 期
Randomised, open label, phase 1 study of aspirin in sepsis patients in ICU to determine the PK/PD of aspirin.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 135
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
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 85 Years（—）
- 性别
- All
入选标准
- •Ninety critically ill adult patients over 18 years of age with SIRS or sepsis (infected site plus SIRS) will be enrolled having given informed consent. Study subjects will be required to have not taken aspirin in the 6 weeks prior to admission to ICU. An untreated control population consisting of 45 patients with SIRS or sepsis that are not treated with aspirin will be recruited and blood samples will be drawn to allow comparison of changes in PD parameters with aspirin treated patients.
排除标准
- •Patients with a contraindication to aspirin due to hypersensitivity to aspirin or NSAID drugs
- •platelet count <100,000×109/l
- •coagulopathy with INR>2 or active bleeding (eg, trauma, gastrointestinal or intracranial bleeding) will be excluded. Patients with pre-existing renal injury as per RIFLE guidelines will be excluded.
- •Patients will have study medications ceased if there is evidence of hypersensitivity to aspirin (new onset of severe bronchospasm or urticarial rash), renal injury (serum creatinine doubling / GFR reducing by > 50%) or new onset of bleeding.
研究者
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