Perioperative Levosimendan Administration in Neonates With Transposition of the Great Arteries: Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- lower inotropic score in the levosimendan group
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Day to 30 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
levosimendan
levosimendan continuous infusion at a rate of 0.1 mcg/kg<min
Intervention: levosimendan (Drug)
levosimendan
levosimendan continuous infusion at a rate of 0.1 mcg/kg<min
Intervention: placebo (Drug)
placebo
saline infusion
Intervention: levosimendan (Drug)
placebo
saline infusion
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
lower inotropic score in the levosimendan group
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)
inotropic score will be calculated as: dopamine (mcg/Kg/min) \* 1 + milrinone (mcg/Kg/min) \* 15 + epinephrine (mcg/Kg/min) \* 100.
Secondary Outcomes
- 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))
Investigators
Zaccaria Ricci
medical doctor
Bambino Gesù Hospital and Research Institute