Levosimendan Versus Milrinone in Off Pump CABG Surgery

Assiut University

Status and phase: Unknown; Phase 4

Conditions: Hemodynamics

Treatments: Drug: Milrinone; Drug: Levosimendan

Study type: Interventional

Funder types: Other

Identifiers

NCT03855579

Levosimendan, Milrinone, CABG

Details and patient eligibility

About

To compare the efficacy of Levosimendan versus Milrinone in supporting hemodynamics during off-pump coronary artery bypass grafting surgery in patients with low ejection fraction.

Full description

The major challenge during off-pump coronary artery bypass graft surgery is to maintain optimum hemodynamics by optimizing the intravascular volume and by using some inotropes. However, conventional inotropes such as beta-agonists are associated with tachycardia and arrhythmia which increase myocardial oxygen demand.

Levosimendan is an inodilator which exerts its positive inotropic effect by enhancing the sensitivity of troponin C to calcium without increasing intracellular calcium concentration. Levosimendan also decreases the systemic vascular resistance, so, it increases the cardiac output without increasing myocardial oxygen consumption.

This study aims to compare the efficacy of Levosimendan versus Milrinone in supporting hemodynamics during off-pump coronary artery bypass grafting surgery in patients with low ejection fraction.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective off-pump coronary artery bypass grafting surgery.
• ejection fraction < 50%

Exclusion criteria

• Patients with severe renal impairment or renal failure.
• Patients on mechanical support (intra-aortic balloon pump)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Levosimendan

Experimental group

Description:

Intraoperative infusion of Levosimendan

Treatment:

Drug: Levosimendan

Milrinone

Active Comparator group

Description:

Intraoperative infusion of Milrinone

Treatment:

Drug: Milrinone