Levosimendan Versus Milrinone in Off Pump CABG Surgery

Hemodynamics Clinical Trial

Official title:

Levosimendan Versus Milrinone to Support Hemodynamics During Off Pump Coronary Artery Bypass Grafting Surgery in Patients With Poor Ejection Fraction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03855579
• Other study ID #: Levosimendan, Milrinone, CABG
• Status: Recruiting
• Phase: Phase 4
• Start date: March 6, 2019
• Est. completion date: September 10, 2019

Study information

• Verified date: March 2019
• Source: Assiut University
• Contact: Hany M. Osman, M.D.
• Phone: +201002414591
• Email: hanymeo[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 10, 2019
• Est. primary completion date: September 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hemodynamics

Intervention

Drug:
• Levosimendan
Intraoperative infusion of Levosimendan
• Milrinone
Intraoperative infusion of Milrinone

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean blood pressure		Intraoperative
Primary	Consumption of other inotropes		Intraoperative