Study of Metabolic Syndrome in Patients Undergoing Endovascular Aortic Repair (EVAR)
试验速览
- 阶段
- 不适用
- 入组人数
- 220
- 主要终点
- Mortality
研究概览
简要总结
This prospective study aims to identify the prevalence of metabolic syndrome in patients undergoing EVAR and the implications of metabolic syndrome on the postoperative outcome, the major complications, the thromboembolic events and the perioperative mortality and morbidity of the patients undergoing vascular surgery.
详细描述
Patients scheduled for elective EVAR will be randomly divided in two groups. One group patients with metabolic syndrome and one without.
Metabolic syndrome is defined by the definition of 2009 as:
Increased waist circumflex (>94 cm in men and > 80 cm in women), increased triglycerides or in therapy, decreased HDL (< 40 mg/dl in men and <50mg/dl in women) or in therapy, Increased blood pressure (Systolic Blood Pressure>130 mmHg or Diastolic Blood Pressure>85 mmHg) or in therapy, increased fasting glucose (>100mg/dl) or in therapy.
All the patients will be monitored throughout the perioperative period, at 30 days, 6 and 12 months, and any major or minor complication will be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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 EVAR
排除标准
- •Patients incapable to give informed consent
- •Pregnancy
- •Systematic Inflammatory disease
- •Use of steroids
- •Emergency surgery
- •Prior ICU admission
结局指标
主要结局
Mortality
时间窗: 12 months
Patients after EVAR who died in 12 months
次要结局
- Systematic inflammatory response(12 months)
- Postimplantation syndrome(12 months)
- Renal insufficiency(12 months)
- Cardiovascular events(12 months)
- Thromboembolic events(12 months)
- Complications of surgical procedure(12 months)
研究者
Elena Arnaoutoglou
Professor of Anesthesiology
University of Thessaly