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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
882
matching placebo
Number of Dual Efficacy Endpoint Events
The all-cause death at 30 days or use of mechanical assist device (IABP, LVAD or ECMO) following the start of surgery for poor cardiac function despite inotropic support and adequate fluid replacement) through Day 5
Time frame: 30 days
Number of Quad Efficacy Endpoint Events
Composite of all-cause death (at 30 days), or perioperative nonfatal MI \[CK-MB \>10xULN or \>100 ng/mL, CK-MB \>5xULN or 50 ng/mL with new Q wave (\>0.04 seconds wide in two contiguous leads) or new left bundle branch block)\] (through Day 5), or need for renal dialysis (through Day 30), or use of mechanical assist device (IABP, LVAD or ECMO) following the start of surgery for poor cardiac function despite inotropic support and adequate fluid replacement) (through Day 5)
Time frame: 30 days
Duration of Intensive Care Unit/Critical or Coronary Care Unit (ICU/CCU) (Days)
Duration of intensive care unit/critical or coronary care unit (ICU/CCU) length of stay (LOS) in days
Time frame: participants will be followed for during the participant's hospital stay up to 30 days
Incidence of Low Cardiac Output Syndrome (LCOS)
Use of a mechanical cardiac assist device within 5 days after surgery, two consecutive measurements of low cardiac output (defined as a cardiac output of ≤2.0 liters per minute per square meter of bodysurface area), one measurement of low cardiac output plus the use of two or more inotropes at or beyond 24 hours after surgery, or the use of two or more inotropes at or beyond 24 hours after surgery with the indicated reason being low cardiac output.
Time frame: 5 days
Postoperative Use of Secondary Inotrope
Use of (dobutamine, milrinone, epinephrine, dopamine) associated with index surgical procedure at 24 hours after initiation of surgery
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University of Alabama at Burlington Hospital
Burlington, Alabama, United States
Huntsville Hospital
Huntsville, Alabama, United States
Mercy General Hospital
Sacramento, California, United States
University of California San Diego Medical Center
San Diego, California, United States
Stanford University School of Medicine
Stanford, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale-New Haven Hospital
New Haven, Connecticut, United States
Boca Raton Community Hospital
Boca Raton, Florida, United States
Shands Hospital at the University of Florida
Gainesville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
...and 50 more locations
Time frame: 24 hours