Levosimendan Administration in Neonates With Transposition of the Great Arteries
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Low Cardiac Output Syndrome |
Drug: levosimendan Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Perioperative Levosimendan Administration in Neonates With Transposition of the Great Arteries: Randomized Controlled Trial |
- 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) ] [ Designated as safety issue: No ]inotropic score will be calculated as: dopamine (mcg/Kg/min) * 1 + milrinone (mcg/Kg/min) * 15 + epinephrine (mcg/Kg/min) * 100.
- Low cardiac output syndrome (LCOS) incidence reduction in the treatment 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) ] [ Designated as safety issue: Yes ]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
| Enrollment: | 63 |
| Study Start Date: | January 2009 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: levosimendan
levosimendan continuous infusion at a rate of 0.1 mcg/kg<min
|
Drug: levosimendan
patients enrolled in this group will receive a levosimendan continuous infusion at a rate of 0.1 mcg/kg/min
Other Name: simdax
Drug: placebo
saline continuous infusion
Other Name: saline
|
|
Placebo Comparator: placebo
saline infusion
|
Drug: levosimendan
patients enrolled in this group will receive a levosimendan continuous infusion at a rate of 0.1 mcg/kg/min
Other Name: simdax
Drug: placebo
saline continuous infusion
Other Name: saline
|
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.
Eligibility| Ages Eligible for Study: | up to 30 Days |
| Genders Eligible for Study: | Both |
| 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)
Contacts and Locations
More Information
Publications:
| Responsible Party: | Zaccaria Ricci, medical doctor, Bambino Gesù Hospital and Research Institute |
| ClinicalTrials.gov Identifier: | NCT01120106 History of Changes |
| Other Study ID Numbers: | levoTGA1 |
| Study First Received: | May 6, 2010 |
| Last Updated: | June 22, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Bambino Gesù Hospital and Research Institute:
|
levosimendan pediatric cardiac surgery low cardiac output syndrome transposition of the great arteries |
Additional relevant MeSH terms:
|
Cardiac Output, Low Transposition of Great Vessels Heart Diseases Cardiovascular Diseases Signs and Symptoms Heart Defects, Congenital Cardiovascular Abnormalities Congenital Abnormalities Simendan Anti-Arrhythmia Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Cardiotonic Agents Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vasodilator Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013