Prophylactic Preoperative Inatraaortic Balloon Pump (IABP) in High-risk Patients Undergoing Coronary Artery Bypass Surgery (CABG)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Myocardial Infarction
- Sponsor
- University of Giessen
- Locations
- 1
- Primary Endpoint
- 30-day all-cause mortality post CABG [%]
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Dr. Philippe Grieshaber
MD
University of Giessen
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
30-day all-cause mortality post CABG [%]
Time Frame: 30 days
Secondary Outcomes
- 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)