Levosimendan Administration in Neonates With Transposition of the Great Arteries

Phase 2

Completed

• Conditions: Low Cardiac Output Syndrome
• Interventions: Drug: levosimendan; Drug: placebo

• Registration Number: NCT01120106
• Lead Sponsor: Bambino Gesù Hospital and Research Institute

Brief 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.

Detailed 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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-05-06
• Study First Submitted QC: 2010-05-07
• Study First Posted: 2010-05-10
• Primary Completion: 2010-12
• Study Completion: 2011-09
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-22
• Last Update Posted: 2012-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
levosimendan	placebo	levosimendan continuous infusion at a rate of 0.1 mcg/kg\<min
placebo	placebo	saline infusion
levosimendan	levosimendan	levosimendan continuous infusion at a rate of 0.1 mcg/kg\<min
placebo	levosimendan	saline infusion

Primary Outcome Measures

Name	Time	Method
lower inotropic score in the levosimendan group	Time points: from T0 (within 1 hour of intensive care unit admission) to T7 (72nd post operative hour) through T2, T3, T4, T5, T6, T7)	inotropic score will be calculated as: dopamine (mcg/Kg/min) \* 1 + milrinone (mcg/Kg/min) \* 15 + epinephrine (mcg/Kg/min) \* 100.

Secondary Outcome Measures

Name	Time	Method
Low cardiac output syndrome (LCOS) incidence reduction in the treatment group	Time points: from T0 (within 1 hour of intensive care unit admission) to T7 (72nd post operative hour) through T2, T3, T4, T5, T6, T7)	LCOS will be estimated by the analysis of average heart rate, mean arterial pressure, left atrial pressure, lactates and pH during the evaluated time frame

Trial Locations

Locations (1)

Bambino Gesù Hospital; 🇮🇹 Rome, Italy