跳至主要内容
临床试验/NCT00994903
NCT00994903已完成3 期

Prospective, Double-Blinded, Multi-Centred, Randomised Controlled Trial of Perioperative Simvastatin Use in Elective Colorectal Surgery

University of Auckland, New Zealand3 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2011年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
132
试验地点
3
主要终点
Total complications

研究概览

简要总结

Statins (HMG-CoA reductase inhibitors) are a widely used class of cholesterol-lowering drugs that have an established role in the medical management of cardiovascular disease. Their benefits have also been shown in the surgical setting with decreased cardiovascular complications and lower perioperative mortality following cardiac and vascular surgery. There is now considerable evidence showing statins have useful pleiotropic properties that extend beyond cholesterol lowering, including anti-inflammatory, anti-oxidant, immunomodulatory and fibrinolytic effects. Growing evidence suggests these effects may be useful in attenuating the proinflammatory and metabolic stress response to surgery and the benefit of statins may extend to other surgical settings such as abdominal surgery.

Laboratory studies demonstrate the surgically-relevant benefits of statins and show they decrease peritoneal inflammation, reduce the severity of intestinal ischaemia-reperfusion injury, improve survival in models of abdominal sepsis, decrease the formation of postoperative intraperitoneal adhesions and improve the healing of colonic anastomoses. Retrospective clinical studies show statins improve outcomes in sepsis, reduce the postoperative systemic inflammatory response syndrome (SIRS) and are associated with decreased rates of surgical wound infections and postoperative respiratory complications following various non-cardiac general surgical procedures. However, no prospective studies have specifically evaluated the perioperative use of statins in abdominal surgery. Using colorectal surgery as a model for major abdominal surgery, the investigators will conduct a randomised controlled trial evaluating the effect of perioperative statin use on postoperative morbidity, local and systemic inflammatory response, and functional recovery after surgery.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Placebo

Placebo Comparator

Placebo tablets (Inert calcium lactate)

干预措施: Placebo (Drug)

Simvastatin

Experimental

40mg of Simvastatin given 3-7 days pre-op and continued till 14 days post-op

干预措施: Simvastatin (Drug)

结局指标

主要结局

Total complications

时间窗: Up to post-operative day 30

Complications pre-defined and graded by the Clavien-Dindo classification

次要结局

  • Peritoneal Cytokines(Postoperative Day 1)
  • Serum cytokines(Post-operative Day 1)
  • Change in serum C-reactive protein (CRP)(Baseline and Postoperative Day 1, 2 and 3)
  • Change in functional recovery(Baseline and Postoperative Day 1, 3, 7, 14, and 30)

研究者

发起方
University of Auckland, New Zealand
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew G Hill

Professor Andrew Hill

University of Auckland, New Zealand

研究点 (3)

Loading locations...

相似试验

Simvastatin in Colorectal Surgery | 临床试验