Levosimendan Administration in Neonates With Transposition of the Great Arteries

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Low Cardiac Output Syndrome

Intervention / Treatment
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* Drug: levosimendan
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: levosimendan<br>levosimendan continuous infusion at a rate of 0.1 mcg/kg<min | Drug: levosimendan<br>* patients enrolled in this group will receive a levosimendan continuous infusion at a rate of 0.1 mcg/kg/min<br>* Other names: simdax;Drug: placebo<br>* saline continuous infusion<br>* Other names: saline;|
| Placebo Comparator: placebo<br>saline infusion | Drug: levosimendan<br>* patients enrolled in this group will receive a levosimendan continuous infusion at a rate of 0.1 mcg/kg/min<br>* Other names: simdax;Drug: placebo<br>* saline continuous infusion<br>* Other names: saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lower inotropic score in the levosimendan group | inotropic score will be calculated as: dopamine (mcg/Kg/min) * 1 + milrinone (mcg/Kg/min) * 15 + epinephrine (mcg/Kg/min) * 100. | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low cardiac output syndrome (LCOS) incidence reduction in the treatment group | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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levosimendan, pediatric cardiac surgery, low cardiac output syndrome, transposition of the great arteries