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Levosimendan Administration in Neonates With Transposition of the Great Arteries

Low Cardiac Output Syndrome Clinical Trial

Official title:
Perioperative Levosimendan Administration in Neonates With Transposition of the Great Arteries: Randomized Controlled Trial

Clinical Trial Summary

Calcium sensitizer drugs such as Levosimendan may exert anti-ischemic effect in addition to positive inotropic and anti-stunning effects mediated by the opening of ATP-sensitive potassium (KATP) channels. The aim of the study is to test the myocardial protection effect of peri-operative iv infusion of Levosimendan in a cohort of neonates affected by transposition of the great arteries undergoing surgical correction by arterial switch.

Clinical Trial Description

Function of the myocardium of neonates with congenital heart disease may be affected by several factors in post operative phase: congenital insufficiency, cardiopulmonary bypass low perfusion, ischemima during the cross-clamp phase, low cardiac output syndrome, systemic inflammation. Furthermore, neonates have immature molecular mechanisms leading to calcium utilization inside myocytes. Calcium sensitizer drugs such as Levosimendan may exert anti-ischemic effect in addition to positive inotropic and anti-stunning effects mediated by the opening of ATP-sensitive potassium (KATP) channels. The aim of the study is to test the inodilator and myocardial protection effect of peri-operative iv infusion of 0.1 mcg/kg/min Levosimendan (without previuos bolus) in a cohort of neonates affected by transposition of the great arteries undergoing surgical correction by arterial switch. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01120106
Study type Interventional
Source Bambino Gesù Hospital and Research Institute
Contact
Status Completed
Phase Phase 2
Start date January 2009
Completion date September 2011
View Details
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