Comparison Between Levosimendan and Adrenaline in CABG Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2024-05-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Open Heart Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group (L) levosimendan group

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

Group Type EXPERIMENTAL

Levosimendan

Intervention Type DRUG

Patients in this group will receive levosimendan

Group (A) Adrenaline group

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

Group Type ACTIVE_COMPARATOR

Adrenaline

Intervention Type DRUG

Patients in this group will receive Adrenaline

Interventions

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Levosimendan

Patients in this group will receive levosimendan

Intervention Type DRUG

Adrenaline

Patients in this group will receive Adrenaline

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No