跳至主要内容
临床试验/NCT01950130
NCT01950130撤回不适用

Prophylactic Preoperative Inatraaortic Balloon Pump (IABP) in High-risk Patients Undergoing Coronary Artery Bypass Surgery (CABG)

University of Giessen1 个研究点 分布在 1 个国家开始时间: 2015年6月1日最近更新:
适应症
干预措施

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

Experimental

Preoperative IABP insertion

干预措施: Preoperative IABC (Procedure)

Control group

No Intervention

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Philippe Grieshaber

MD

University of Giessen

研究点 (1)

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