Levosimendan Administration in Neonates With Transposition of the Great Arteries

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01120106

Enrollment

Registered

2010-05-10

Start date

2009-01-31

Completion date

2011-09-30

Last updated

2012-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Cardiac Output Syndrome

Keywords

levosimendan, pediatric cardiac surgery, low cardiac output syndrome, transposition of the great arteries

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.

Interventions

DRUGlevosimendan

patients enrolled in this group will receive a levosimendan continuous infusion at a rate of 0.1 mcg/kg/min

DRUGplacebo

saline continuous infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Days to 30 Days

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026