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Levosimendan Versus Milrinone in Off Pump CABG Surgery

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03855579
Enrollment
60
Registered
2019-02-27
Start date
2019-03-06
Completion date
2019-09-10
Last updated
2019-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamics

Keywords

Levosimendan, Milrinone, Off-pump, Coronary

Brief 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.

Detailed 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.

Interventions

DRUGLevosimendan

Intraoperative infusion of Levosimendan

DRUGMilrinone

Intraoperative infusion of Milrinone

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Mean blood pressureIntraoperative
Consumption of other inotropesIntraoperative

Countries

Egypt

Contacts

Primary ContactHany M. Osman, M.D.
hanymeo@aun.edu.eg+201002414591
Backup ContactFatma Mohamed, M.D.
fatmanabil2012@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026