Clinical trial NCT05222256: Comparison Between Levosimendan and Adrenaline in CABG Patients
Official title: Levosimendan Versus Adrenaline in Patients With Low Left Ventricular Function Undergoing Elective On-Pump Coronary Artery Bypass Graft Surgery. A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Open Heart Surgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Systolic function (EF) will be measured in both groups Levosemindan and Adrenaline in patients with low ejection fraction (30-40%), undergoing elective on pump Coronary Artery Bypass Graft (CABG).
timeFrame: 24 hour
Secondary outcomes:
measure: LV Myocardial Performance (Tei) Index will be measured in both groups
timeFrame: 24 hour
measure: LV Stroke Volume and Cardiac Output will be measured in both groups
timeFrame: 24 hour
measure: LV diastolic function will be measured in both groups
timeFrame: 24 hour
Other outcomes:
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