Use of Rosuvastatin in Integral Management of Abdominal Sepsis
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Plasmatic levels of Interleukine 6 and 1B, and Tumor Necrosis Factor alpha (pg/dL)
研究概览
简要总结
The purpose of this study is to determine whether rosuvastatin is effective as a coadjuvant drug in the integral management of abdominal sepsis acknowledged by surgery.
详细描述
The sepsis is often lethal, the mortality's ranks are identified among 25 to 70%, this depends on definition, severity and co-morbidities. The number of deaths by sepsis could be similar to myocardial infarct. Patients who get shock have 26-fold risk of death.
In preliminary studies have been observed, that patients with treatment with statin have minor incidence of severe sepsis. A retrospective study suggests the association between using statins and reduction of bacteriemia by Gram negatives and S. aureus.
There are many experimental studies which demonstrate the possible profit in sepsis. However there are no clinical prospective studies for determinate if statins are effective in management of sepsis. The investigators designed this study to demonstrate the utility of rosuvastatin in one kind of sepsis, abdominal sepsis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or women > 18 and < 80 years old with abdominal sepsis, confirmed diagnosis by surgery of broad peritonitis before 48 hours in progression
- •Injury by steel or firearm with contaminated abdominal cavity
- •APACHE II major or equal than 8
- •Acceptance to be included
排除标准
- •Ingestion of: fibrates, niacin, cyclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem, amiodarone
- •Hypovolemic shock III and IV after get surgery
- •Cardio-respiratory failure pre or trans surgery
- •Allergy to used drug
- •Use previous of statin
- •Hepatopathy or myopathy and(or) history, hepatic failure (Child B y C)
- •Management in other Hospital
- •Thoracic injury, head injury (moderate and severe), multiple fractures or with bone exposition, rectal injury
结局指标
主要结局
Plasmatic levels of Interleukine 6 and 1B, and Tumor Necrosis Factor alpha (pg/dL)
时间窗: day 3
次要结局
- Number of survivors(1 week after randomization)
- Plasmatic levels of Reactive C Protein (mg/dL)(day 3)
- Classification of severity by APACHE II scale(day 3)
- Incidence of complications or secondary effects(day 1, 3, 7, 14 after randomization)