Preoperative Infusion of Levosimendan in Patients Undergoing Cardiac Surgery

Study Overview
=================
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.

Official Title
-----------------
Preoperative Infusion of Levosimendan in High Risk Cardiac Surgery Patients: A Retrospective Study

Conditions
-----------------
Cardiac Disease, Cardiac Failure, Cardiac Surgery, Inotropes, Ejection Fraction

Intervention / Treatment
-----------------
* Procedure: preoperative infusion of levosimendan
* Procedure: no preoperative infusion of levosimendan


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Retrospective
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: patients who were administered levosimendan at a dose of 0.1µg/Kg/min for 24 hours prior to surgery<br> | Procedure: preoperative infusion of levosimendan<br>* 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<br>|
| Placebo Comparator: patients who were not administered levosimendan prior to surgery<br> | Procedure: no preoperative infusion of levosimendan<br>* the control group will consist of patients who proceeded to the cardiac operation without any infusion for 24 hours preoperatively<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hours of mechanical ventilation | hours of mechanical ventilation during patient stay in Intensive Care Unit (ICU) | during stay in ICU, approximately 48 hours postoperatively | 
| vasopressor use in operating room | need for vasopressor use, yes or no | intraoperatively, from induction to end of anesthesia, an average period of 3 hours | 
| vasopressor use in ICU | need for vasopressor use, yes or no | during stay in ICU, approximately 48 hours postoperatively | 
| inotrope use in operating room | need for inotrope use, yes or no | intraoperatively, from induction to end of anesthesia, an average period of 3 hours | 
| inotrope use in ICU | need for inotrope use, yes or no | during stay in ICU, approximately 48 hours postoperatively | 
| incidence of arrhythmias | development of new-onset arrhythmias, yes or no | 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 | postoperatively, an average period of 7-10 days | 
| length of ICU stay | duration of patient stay in ICU in days | postoperatively, an average period of 7-10 days | 
| hospitalization time | duration of hospital stay after surgery in days | 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 | 30 days after surgery | 
| need of mechanical assist devices intraoperatively | need for mechanical assist devices, yes or no | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 10 minutes after anesthesia induction, 10 minutes after bypass discontinuation, end of operation (an average period of 3 hours after start of surgery) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
levosimendan, low output syndrome