Preoperative Infusion of Levosimendan in Patients Undergoing Cardiac Surgery

Not Applicable

Completed

• Conditions: Inotropes; Cardiac Surgery; Ejection Fraction; Cardiac Disease; Cardiac Failure
• Interventions: Procedure: no preoperative infusion of levosimendan; Procedure: preoperative infusion of levosimendan

• Registration Number: NCT04635293
• Lead Sponsor: Aretaieion University Hospital

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.

Study Timeline

• Study Start: 2012-01-01
• Status Verified: 2020-11
• Primary Completion: 2020-11-09
• Study Completion: 2020-11-09
• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-11-12
• Last Update Submitted: 2020-11-12
• Study First Posted: 2020-11-19
• Last Update Posted: 2020-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients who were not administered levosimendan prior to surgery	no preoperative infusion of levosimendan	-
patients who were administered levosimendan at a dose of 0.1µg/Kg/min for 24 hours prior to surgery	preoperative infusion of levosimendan	-

Primary Outcome Measures

Name	Time	Method
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
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
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
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
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
length of ICU stay	postoperatively, an average period of 7-10 days	duration of patient stay in ICU in days
incidence of arrhythmias	postoperatively, an average period of 7-10 days	development of new-onset arrhythmias, yes or no
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
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 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 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 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

Trial Locations

Locations (1)

Onassis Cardiac Surgery Center; 🇬🇷 Athens, Greece