Comparison Between Levosimendan and Adrenaline in CABG Patients

Assiut University

Status: Unknown

Conditions: Open Heart Surgery

Treatments: Drug: Levosimendan; Drug: Adrenaline

Study type: Interventional

Funder types: Other

Identifiers

NCT05222256

Tee in open heart surgery

Details and patient eligibility

About

The aim of this study is to compare between levosimendan and adrenaline in patients with pre-existing impaired systolic function (EF 30-40%), undergoing elective on-pump CABG, as regards hemodynamics and echocardiographic parameters.

Full description

Patients undergoing cardiac surgery are at risk of post-cardiotomy myocardial dysfunction. This condition causes delayed recovery, organ failure, prolonged intensive care unit and hospital stays, and an increased risk of mortality. These patients often require inotropic support, which has been associated with an increased risk of cardiovascular complications. Treatment of myocardial dysfunction includes optimization of myocardial contractility through appropriate fluid and pharmacologic management and mechanical support . Extensive use of inotropes in this situation is needed, but the optimal pharmacologic management of myocardial dysfunction in cardiac surgery is a matter of ongoing debate .Available inotropes including adrenaline may increase myocardial oxygen consumption, heart rate and risk of arrhythmia. An increase in myocardial oxygen consumption by inotropes in a state of inadequate oxygen delivery may further deteriorate underlying cardiac dysfunction and even lead to increased mortality . There are questions regarding the ideal inotrope to use during the post cardiopulmonary bypass (CPB) period in patients undergoing on-pump CABG surgery. The occurrence of myocardial dysfunction after cardiac surgery is a potential indication for the use of levosimendan, a calcium sensitizer with a unique mechanism of action. By binding to cardiac troponin C, it enhances myofilament responsiveness to calcium, thereby increasing myocardial contraction without increasing myocardial oxygen consumption. In addition, levosimendan activates adenosine triphosphate-dependent potassium channels, which are important mediators of ischemic and anesthetic cardioprotection. Levosimendan might thus have a potential benefit for patients with myocardial oxygen imbalance requiring inotropic drug support . The hypothesis of the present study is that levosimendan without loading dose can improve myocardial function and provide better hemodynamics as well as echocardiographic parameters compared with adrenaline in patients with low ejection fraction undergoing op-pump CABG

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ischemic hear disease
• age 18 and 65 years
• low left ventricular function (ejection fraction 30 - 40%),
• elective coronary artery bypass grafting (CABG) surgery

Exclusion criteria

• Age over 65 years
• Patients with end organ failure (renal, liver)
• Associated significant valve lesions
• Uncontrolled diabetes mellitus
• Emergency surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Group (L) levosimendan group

Experimental group

Description:

Patients in this group will receive levosimendan (0.1 μg/kg/min) during re-warming of the patients.

Treatment:

Drug: Levosimendan

Group (A) Adrenaline group

Active Comparator group

Description:

Patients in this group will receive Adrenaline (0.05 μg /kg/min) during re-warming of the patients.

Treatment:

Drug: Adrenaline