Cardiac Disease, Cardiac Failure, Cardiac Surgery, Ejection Fraction, Inotropes
Conditions
Keywords
levosimendan, low output syndrome
Brief summary
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
Detailed description
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.
Interventions
PROCEDUREpreoperative infusion of levosimendan
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
PROCEDUREno preoperative infusion of levosimendan
the control group will consist of patients who proceeded to the cardiac operation without any infusion for 24 hours preoperatively
Sponsors
Aretaieion University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Retrospective
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* elective cardiac surgery * cardiac surgery under cardiopulmonary bypass * low ejection fraction (\<40%)
Exclusion criteria
* age \<18 years old * urgent operation * glomerular filtration rate\<30 ml/min * hepatic dysfunction preoperatively * side effects (hypotension, tachycardia, ST segment abnormalities during levosimendan administration * redo surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hours of mechanical ventilation | during stay in ICU, approximately 48 hours postoperatively | hours of mechanical ventilation during patient stay in Intensive Care Unit (ICU) |
| vasopressor use in operating room | intraoperatively, from induction to end of anesthesia, an average period of 3 hours | need for vasopressor use, yes or no |
| vasopressor use in ICU | during stay in ICU, approximately 48 hours postoperatively | need for vasopressor use, yes or no |
| inotrope use in operating room | intraoperatively, from induction to end of anesthesia, an average period of 3 hours | need for inotrope use, yes or no |
| inotrope use in ICU | during stay in ICU, approximately 48 hours postoperatively | need for inotrope use, yes or no |
| incidence of arrhythmias | postoperatively, an average period of 7-10 days | development of new-onset arrhythmias, yes or no |
| incidence of renal dysfunction | postoperatively, an average period of 7-10 days | development of new-onset renal dysfunction, defined as an increase in creatinine levels over 0.3 mg/dL from the initial values |
| length of ICU stay | postoperatively, an average period of 7-10 days | duration of patient stay in ICU in days |
| hospitalization time | postoperatively, up to 20 days after the operation | duration of hospital stay after surgery in days |
| incidence of death within the first 30 days after surgery | 30 days after surgery | patient survival within the first 30 days after surgery, yes or no |
| need of mechanical assist devices intraoperatively | intraoperatively, from induction to end of anesthesia, an average period of 3 hours and postoperatively, an average period of 7-10 days | need for mechanical assist devices, yes or no |
| need of mechanical assist devices postoperatively | postoperatively, an average period of 7-10 days | need for mechanical assist devices, yes or no |
| change from baseline in cardiac output (CO) | 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, | a Swan-Ganz catheter will be used for hemodynamic measurements |
| change from baseline in mean arterial pressure (MAP) | 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, | a Swan-Ganz catheter will be used for hemodynamic measurements |
| change from baseline in mean pulmonary arterial pressure (MPAP) | 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, | a Swan-Ganz catheter will be used for hemodynamic measurements |
| change from baseline in systemic vascular resistance (SVR) | 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, | a Swan-Ganz catheter will be used for hemodynamic measurements |
| change from baseline in pulmonary vascular resistance (PVR) | 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, | a Swan-Ganz catheter will be used for hemodynamic measurements |
| change from baseline in pulmonary capillary wedge pressure (PCWP) | 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, | a Swan-Ganz catheter will be used for hemodynamic measurements |
| change from baseline in cardiac function | 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery) | transesophageal echocardiography will be used for echocardiographic measurements |
Countries
Greece
Outcome results
None listed