Does Minimal Extracorporeal Circulation Improve Outcome in Diabetic Patients Undergoing Elective Coronary Bypass Grafting?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 主要终点
- Acute Kidney Injury
研究概览
简要总结
The aim of this study was to prospectively evaluate MECC compared with conventional extracorporeal circulation of diabetic patients undergoing elective coronary revascularization procedures. The investigators focused on the effects of extracorporeal circulation especially the renal function between both groups.
详细描述
Cardiopulmonary bypass (CPB) is known having a negative influence referring to systemic inflammatory reaction after cardiac surgery which can cause acute kidney injury (AKI). Miniaturized extracorporeal circulation (MECC) attempts to reduce the adverse effects of conventional extracorporeal circulation bypass. Finally, AKI after CPB is a significant clinical problem that increasingly complicates the course of hospitalization and clinical outcome.
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
- Single (Participant)
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
- •diabetes mellitus type 2
- •isolated elective coronary revascularization
排除标准
- •urgent or emergent Status
- •Re-Operation
- •preexisting reanimation
- •preexisting renal transplantation
- •chronic kidney insufficiency (GFR < 30 ml/min)
- •renal cell carcinoma
- •renal artery Stenosis
- •heart valve disease (middle- and high-grade)
- •endocarditis
- •infections (HIV, Tbc and all types of Hepatitis)
- •hepatic cirrhosis
结局指标
主要结局
Acute Kidney Injury
时间窗: within the first 30 days (plus or minus 3 days) after surgery
次要结局
未报告次要终点
研究者
PD Dr. Hausmann
chief physician
Herzzentrum Coswig