NCT00881192.

Study name	Perioperative Intra‐Aortic Balloon Pump (IABP) in Coronary Artery Bypass Grafting (CABG) Operations in Patients With Severely Depressed Left Ventricular Function
Methods	RCT
Participants	Estimated Enrollment:160
Interventions	Control: No Intervention No preoperative IABP; if needed, postoperative IABP placement IABP: Active Comparator Preoperative IABP placement
Outcomes	Primary Outcome Measures: Major morbidity according to STS (mechanical ventilation > 48 hours, mediastinitis, surgical reexploration, stroke, acute renal failure) [ Time Frame: 30 days after operation ] [ Designated as safety issue: No ] Secondary Outcome Measures: Time on mechanical ventilation; ICU and hospital stay [ Time Frame: 30 days after the operation ] [ Designated as safety issue: No ] IABP complications (lower limb ischaemia, mesenteric ischaemia, bleeding) [ Time Frame: 30 days after the operation ] [ Designated as safety issue: Yes ]
Starting date	Study Start Date: April 2009
Contact information	Policlinico S. Donato
Notes	RCT including patients scheduled for elective CABG surgery (with or without associated procedures) and having a left ventricular ejection fraction < 0.30. Exclusion criteria: age < 18 years, no patient's consent, contra‐indications to the use of IABP (severe peripheral arteriopathy; endovascular abdominal aortic prostheses). Patients will be randomly allocated to either a control group or a treatment group. Patients in the control group will not receive an IABP preoperatively, and patients in the treatment arm will receive an IABP positioned immediately after the induction of anaesthesia and before beginning surgery. Randomization will be performed the day before the operation. Primary endpoint: reduction of major morbidity rate (defined as either prolonged (> 48 hours) mechanical ventilation, acute renal failure, mediastinitis, surgical revision, stroke). Secondary endpoint: reduction in inotropic drug use, shortening of mechanical ventilation and ICU stay. http://clinicaltrials.gov/ct2/show/NCT00881192