Can Goal Directed Hemodynamic Management Improve Renal Outcome After Major Non-cardiac Surgery?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- maximum change in serum creatinine within 3 days
研究概览
简要总结
This study is designed to compare renal outcome of patients following major non-cardiac surgery with different perioperative hemodynamic managements: a goal directed hemodynamic management group (using PiCCO) and a control group.
详细描述
Acute kidney injury (AKI) is a common complication after major surgery. Many studies showed that AKI is associated with different complications: higher mortality, renal replacement therapy and prolonged hospital stay resulting in higher health care costs.
Until now just a few studies are published on prevention or therapy of AKI after major surgery. Most of these investigations are underpowered or show just marginal benefit. There are no studies published investigating the impact of goal-directed hemodynamic management on renal outcome following non-cardiac major surgery, even though hemodynamic stability seems to be of paramount importance for the kidneys.
Aim of this study is to investigate the impact of a goal directed hemodynamic management on renal outcome after major non-cardiac surgery.
Therefore patients will be randomized in one of two groups, the PiCCO group with goal directed hemodynamic management and the Control group, where PICCO data will be collected but will not influence hemodynamic management. In both groups the monitoring with transpulmonary thermodilution will be continued in the intensive care unit until 72 hours after surgery.
研究设计
- 研究类型
- Observational
- 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 major non-cardiac surgery lasting more than 3 hours with a following intensive care unit stay for more than 3 days:
- •gastrectomy
- •pancreas surgery
- •small bowel surgery
- •esophageal surgery
- •Age ≥ 18 years
- •ASA classification I to III
- •Written informed consent
排除标准
- •Need for dialysis
- •Contraindications for an arterial line in the femoral artery:
- •severe peripheral artery occlusive disease
- •ASA classification IV to V
- •Pregnant Woman
结局指标
主要结局
maximum change in serum creatinine within 3 days
时间窗: Start of anesthesia until third postoperative day (72 hours)
次要结局
- incidence of AKI according to the RIFLE criteria, need for dialysis, pulmonal complications, rate of anastomotic insufficiency, sepsis, reoperation(1 year)