Clinical trial NCT01950130: Prophylactic IABP in High-risk Patients Undergoing CABG
Official title: Prophylactic Preoperative Inatraaortic Balloon Pump (IABP) in High-risk Patients Undergoing Coronary Artery Bypass Surgery (CABG)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Myocardial Infarction
Coronary Artery Disease
Keywords: IABP
IABC
coronary artery disease
prophylactic
cardiac assist
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2013-09-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key inclusion criteria:

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.

Key exclusion criteria:

* 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

Primary outcomes:
measure: 30-day all-cause mortality post CABG [%]
timeFrame: 30 days
Secondary outcomes:
measure: Survival at 3, 6, 12 months [%]
timeFrame: 3, 6 and 12 months
measure: Duration of ICU stay [h]
timeFrame: 48 hours (average)
measure: Dependence on medical inotropic support
timeFrame: 48 hours (average)
measure: IABP-associated complications
timeFrame: 8 days (average)
Other outcomes:
Locations:
city: Giessen
country: Germany
facility: Department of Adult and Pediatric Cardiovascular Surgery
Study officials:
affiliation: Giessen University
name: Philippe Grieshaber, MD
role: STUDY_DIRECTOR
References: