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Clinical Trials/NCT05222256
NCT05222256CompletedNot Applicable

Levosimendan Versus Adrenaline in Patients With Low Left Ventricular Function Undergoing Elective On-Pump Coronary Artery Bypass Graft Surgery. A Randomized Controlled Study

Assiut University1 site in 1 country60 target enrollmentStarted: March 25, 2022Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
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).

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Group (A) Adrenaline group

Active Comparator

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

Intervention: Adrenaline (Drug)

Outcomes

Primary Outcomes

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).

Time Frame: 24 hour

transesophageal echo (TEE) will be continuously used to monitor LV systolic and diastolic function during surgery and recordings will be made simultaneously with hemodynamic measurements. LV Ejection Fraction In the transgastric mid-papillary view, the echo machine will be switched to M-mode and the following measurements will be taken: o LV end-diastolic diameter o LV end-systolic diameter The machine will then calculate the LV ejection fraction according to Teich's method

Secondary Outcomes

  • LV Myocardial Performance (Tei) Index will be measured in both groups(24 hour)
  • LV diastolic function will be measured in both groups(24 hour)
  • LV Stroke Volume and Cardiac Output will be measured in both groups(24 hour)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Abdelrahman Mohamed Abdelhafeez Ahmed

Assisstant lecturer of anesthesia and intensive care

Assiut University

Study Sites (1)

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