Levosimendan Versus Milrinone in Off Pump CABG Surgery

NCT ID: NCT03855579

Last Updated: 2019-03-07

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

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-06

Study Completion Date

2019-09-10

Brief Summary

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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

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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.

Conditions

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Hemodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Levosimendan

Intraoperative infusion of Levosimendan

Group Type EXPERIMENTAL

Levosimendan

Intervention Type DRUG

Intraoperative infusion of Levosimendan

Milrinone

Intraoperative infusion of Milrinone

Group Type ACTIVE_COMPARATOR

Milrinone

Intervention Type DRUG

Intraoperative infusion of Milrinone

Interventions

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Levosimendan

Intraoperative infusion of Levosimendan

Intervention Type DRUG

Milrinone

Intraoperative infusion of Milrinone

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Hany Mostafa Esmaeil Osman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Hany M. Osman, M.D.

Role: CONTACT

+201002414591 ext. N.

Fatma Mohamed, M.D.

Role: CONTACT

Facility Contacts

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Hany M. Osman, M.D.

Role: primary

+201002414591

Fatma N. Mohamed, M.D.

Role: backup

+201003633992

Other Identifiers

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Levosimendan, Milrinone, CABG

Identifier Type: -

Identifier Source: org_study_id

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