The aim of this retrospective study will be to investigate the effect of the preoperative administration of levosimendan on the outcome of patients with compromised cardiac function undergoing cardiac surgery
Patients with severely reduced left ventricular ejection fraction (LVEF) face a high risk of morbidity and mortality after cardiac surgery. Impaired cardiac function preoperatively predisposes patients to low cardiac output syndrome. Levosimendan acts by a different mechanism than traditional inotropes and its preoperative use could improve the outcome of patients with cardiac failure. Specifically, it promotes vasodilation of coronary, pulmonary and systemic vessels, has an anti-inflammatory and anti-oxidant effect and enhances cardiac contractility by improving the response of the myofilaments to intracellular calcium. The aim of this retrospective study will be to investigate the effect of the preoperative administration of levosimendan on the outcome of patients with compromised cardiac function undergoing cardiac surgery.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
100
the study group will consist of patients who have received a continuous infusion of levosimendan 0.1 μg/kg/min for 24 hours before cardiac surgery
the control group will consist of patients who proceeded to the cardiac operation without any infusion for 24 hours preoperatively
Onassis Cardiac Surgery Center
Athens, Greece
hours of mechanical ventilation
hours of mechanical ventilation during patient stay in Intensive Care Unit (ICU)
Time frame: during stay in ICU, approximately 48 hours postoperatively
vasopressor use in operating room
need for vasopressor use, yes or no
Time frame: intraoperatively, from induction to end of anesthesia, an average period of 3 hours
vasopressor use in ICU
need for vasopressor use, yes or no
Time frame: during stay in ICU, approximately 48 hours postoperatively
inotrope use in operating room
need for inotrope use, yes or no
Time frame: intraoperatively, from induction to end of anesthesia, an average period of 3 hours
inotrope use in ICU
need for inotrope use, yes or no
Time frame: during stay in ICU, approximately 48 hours postoperatively
incidence of arrhythmias
development of new-onset arrhythmias, yes or no
Time frame: postoperatively, an average period of 7-10 days
incidence of renal dysfunction
development of new-onset renal dysfunction, defined as an increase in creatinine levels over 0.3 mg/dL from the initial values
Time frame: postoperatively, an average period of 7-10 days
length of ICU stay
duration of patient stay in ICU in days
Time frame: postoperatively, an average period of 7-10 days
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hospitalization time
duration of hospital stay after surgery in days
Time frame: postoperatively, up to 20 days after the operation
incidence of death within the first 30 days after surgery
patient survival within the first 30 days after surgery, yes or no
Time frame: 30 days after surgery
need of mechanical assist devices intraoperatively
need for mechanical assist devices, yes or no
Time frame: intraoperatively, from induction to end of anesthesia, an average period of 3 hours and postoperatively, an average period of 7-10 days
need of mechanical assist devices postoperatively
need for mechanical assist devices, yes or no
Time frame: postoperatively, an average period of 7-10 days
change from baseline in cardiac output (CO)
a Swan-Ganz catheter will be used for hemodynamic measurements
Time frame: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
change from baseline in mean arterial pressure (MAP)
a Swan-Ganz catheter will be used for hemodynamic measurements
Time frame: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
change from baseline in mean pulmonary arterial pressure (MPAP)
a Swan-Ganz catheter will be used for hemodynamic measurements
Time frame: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
change from baseline in systemic vascular resistance (SVR)
a Swan-Ganz catheter will be used for hemodynamic measurements
Time frame: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
change from baseline in pulmonary vascular resistance (PVR)
a Swan-Ganz catheter will be used for hemodynamic measurements
Time frame: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery), 12 hours after ICU admittance, 24 hours after ICU admittance,
change from baseline in pulmonary capillary wedge pressure (PCWP)
a Swan-Ganz catheter will be used for hemodynamic measurements
Time frame: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery),12 hours after ICU admittance, 24 hours after ICU admittance,
change from baseline in cardiac function
transesophageal echocardiography will be used for echocardiographic measurements
Time frame: 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery)