EUCTR2007-002454-37-GB进行中（未招募）1 期
Prevention by HMGCoA reductase inhibition of ALI associated with one lung ventilation following oesophagectomy by a Reduction of Pulmonary vascular dysfunction and inflammation (Prevention-HARP) - Acute lung injury post one lung ventilation; effects of simvastatin
The Royal Group Hospitals Trust0 个研究点目标入组 40 人开始时间: 2007年5月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Adult patients undergoing oesophagectomy for oesophageal cancer at the Royal Victoria Hospital, Belfast (RVH)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •age < 18 years
- •creatinine kinase (CK) > 5 times upper limit normal range
- •known active liver disease (Child’s Pugh score > 11), or abnormal liver function tests: transaminases > 3 times upper limit normal range
- •renal impairment (calculated creatinine clearance less than 30mL/minute)
- •inability to take oral medication pre-operatively
- •known lactose intolerance
- •participation in other intervention trials within 30 days
- •pregnancy, breast-feeding or women of childbearing potential not using adequate contraception;
- •patients taking corticosteroids or non-steroidal anti-inflammatory drugs
- •current treatment with statins
- •known hypersensitivity to the study medication
- •a previous adverse reaction to statins
- •concomitant use of fibrates or other lipid-lowering therapy
- •concomitant use of itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, grapefruit juice, cyclosporine, danazol, amiodarone, verapamil or diltiazem.
- •consent declined
研究者
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