NCT00989729已完成不适用
Preoperative Methylprednisolone in Endovascular Aortic Repair - a Randomized Double Blind Placebo Controlled Clinical Trial
Louise de la Motte1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Systemic inflammatory response syndrome - SIRS
研究概览
简要总结
The purpose of this study is to attenuate the systemic inflammatory response after Endovascular repair of abdominal aortic aneurysms, by administration of a single preoperative dosage of Methylprednisolone.
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
- •Elective endovascular repair of an asymptomatic abdominal aortic aneurysm.
- •Informed signed consent
排除标准
- •Positive HIV status, positive hepatitis B or C status
- •Immunoinflammatory disease - except topically treated skin disease and respiratory disease.
- •Gastric or duodenal ulcer
- •Systemic fungal infection
- •Immunosuppressive treatment
- •Current treatment for cancer
- •Allergy towards contents of Solu-Medrol
- •Alcohol consumption: Men > 21 drinks and women > 14 drinks weekly
- •Pregnancy
- •Lack of informed signed consent
- •Patients where follow up is planned at other location than Rigshospitalet.
研究组 & 干预措施
Methylprednisolone
Active Comparator
75 patients will receive a single preoperative dosage of Methylprednisolone
干预措施: Methylprednisolone (Drug)
Physiological Saline
Placebo Comparator
75 patients will receive a single preoperative dosage of Physiological Saline
干预措施: Physiological Saline (Drug)
结局指标
主要结局
Systemic inflammatory response syndrome - SIRS
时间窗: Within 5 postoperative days
次要结局
- Length of postoperative hospital stay(Until discharge)
- Interleukin 6 plasma level(Within 5 postoperative days)
- Adverse events related to Methylprednisolone(Within 5 postoperative days)
研究者
Louise de la Motte
MD
Rigshospitalet, Denmark
研究点 (1)
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