NCT00676897已完成2 期
Study of Statin Therapy in the Treatment of Sepsis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Time to Shock Reversal
研究概览
简要总结
Simvastatin will attenutat IL-6 levels and lead to a more rapid shock reversal than placebo
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than 18 years old
- •Hypotensive requiring vasopressors
- •Suspected Infection
排除标准
- •Liver Failure (ALT or AST > 120)
- •Rhabomyolysis (CPK > 3x normal)
- •Comfort care measures status
- •Chronic Liver Disease (Cirrhosis)
- •Use of Cyclosporin, Digoxin, Statins
- •Patients who are unable to take medications by mouth or NGT
研究组 & 干预措施
1
Experimental
Simvastatin 40 mg PO or NGT
干预措施: Simvastatin (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Shock Reversal
时间窗: up to 7 days
次要结局
- Inflammatory Marker Levels(over 24 hours (time zero and time 24 hours))
研究者
Michael Donnino
Dr. Michael Donnino
Beth Israel Deaconess Medical Center
研究点 (1)
Loading locations...
相似试验
Unknown
4 期
Simvastatin in Patients With Septic ShockSeptic ShockNCT00450840Medical University of Vienna
进行中（未招募）
1 期
Simvastatin in patients with septic shockSeptic shockEUCTR2006-003539-56-ATMedical University of Vienna, Department of Internal Medicine IV40
已完成
不适用
Simvastatin and severe sepsisSevere sepsisInfections and InfestationsSepticaemiaISRCTN92093279Oxford Radcliffe Hospitals NHS Trust (UK)104
终止
2 期
Statins for the Early Treatment of SepsisSepsisNCT00528580University of Chicago68
进行中（未招募）
1 期
SimSepT: Simvastatin and severe sepsis in the ICU - SimSepTSevere sepsisEUCTR2005-003438-17-GBOxford Radcliffe Hospitals NHS Trust200