Prophylactic Preoperative Inatraaortic Balloon Pump (IABP) in High-risk Patients Undergoing Coronary Artery Bypass Surgery (CABG)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- 30-day all-cause mortality post CABG [%]
研究概览
简要总结
Due to advances and increased practice of interventional therapy for coronary artery disease, the rate of high-risk patients with severe coronary disease and reduced left ventricular function among patients undergoing coronary artery bypass grafting surgery (CABG) is increasing. The perioperative mortality in these patients is ≥ 5%. The perioperative and operative management for these patients has to be optimized in order to reduce their perioperative morbidity and mortality. One of the central aspects is perioperative maintenance of hemodynamic stability. The use of prophylactic IABP is a partly established, but not sufficiently evidence-based measure to reduce ventricular afterload and improve coronary perfusion pre-, intra- and postoperatively. Yet, it is an invasive procedure with potential complications. The planned trial should give an explicit answer, whether preoperative prophylactic IABP decreases 30-day all-cause mortality (primary endpoint) and long-term mortality (3, 6, 12 months; secondary endpoints) compared to preoperative conservative treatment in high-risk patients undergoing CABG.
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
- None
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
- •Hemodynamically stable high-risk patients before CABG, defined by the following criteria:
- •Age >18 years
- •Isolated CABG planned
- •Informed consent in trial participation given
- •Any left ventricular functional impairment (regional wall motion abnormality or global LVEF<55%) assessed via ventriculography or transthoracic or transeophageal echocardiography
- •Elevated cardiac biomarkers (CK-MB > 6% of total-CK, Troponin I > 3-fold of specific test reference) or myocardial infarction (NSTEMI or STEMI) within the last 4 days.
排除标准
- •Contraindications for IABP
- •Cardiogenic shock
- •Shock of any other cause
- •Critical preoperative state according to EuroSCORE II-criteria
- •Cardiac surgical procedure other than CABG planned
- •Severe comorbidity with life expectancy < 6 months
- •Incapability of giving informed consent
研究组 & 干预措施
IABP group
Preoperative IABP insertion
干预措施: Preoperative IABC (Procedure)
Control group
Preoperative conservative treatment
结局指标
主要结局
30-day all-cause mortality post CABG [%]
时间窗: 30 days
次要结局
- Duration of ICU stay [h](48 hours (average))
- IABP-associated complications(8 days (average))
- Dependence on medical inotropic support(48 hours (average))
- Survival at 3, 6, 12 months [%](3, 6 and 12 months)
研究者
Dr. Philippe Grieshaber
MD
University of Giessen
