Levosimendan Administration in Neonates With Transposition of the Great Arteries

Bambino Gesù Hospital and Research Institute

Status and phase: Completed; Phase 2

Conditions: Low Cardiac Output Syndrome

Treatments: Drug: levosimendan; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01120106

levoTGA1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 1 to 30 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• neonates affected by transposition of the great arteries scheduled to elective surgery

Exclusion criteria

• neonates affected by transposition of the great arteries who are not scheduled to elective surgery (urgent procedures, patients older than 30 days)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 2 patient groups, including a placebo group

levosimendan

Active Comparator group

Description:

levosimendan continuous infusion at a rate of 0.1 mcg/kg\<min

Treatment:

Drug: placebo

Drug: levosimendan

placebo

Placebo Comparator group

Description:

saline infusion

Treatment:

Drug: placebo

Drug: levosimendan