Conditions: Coronary Artery Bypass Grafting Mitral Valve Surgery Low Cardiac Output Syndrome
Keywords: coronary artery bypass grafting CABG mitral valve LCOS low cardiac output syndrome levosimendan
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 882
Healthy volunteers: no

Brief summary:
A study to evaluate levosimendan compared with placebo in reducing the composite event rate of all-cause death, perioperative MI, need for new dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced ejection fraction undergoing cardiac surgery on cardiopulmonary bypass (CPB).

Detailed description:
This study is being done to evaluate the efficacy of levosimendan compared with placebo in reducing the co-primary endpoints of 30-day composite of all-cause death or use of mechanical assist device (IABP, LVAD or ECMO) or the composite event rate of all-cause death, perioperative MI, need for dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced ejection fraction undergoing cardiac surgery on CPB.

Arms:
arm 1: levosimendan 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours arm 2: placebo 0.2 µg/kg/min for first hour, followed by 0.1 µg/kg/min for an additional 23 hours

Interventions: intervention 1: Levosimendan intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: matching placebo

Protocol document: