Levosimendan Administration in Neonates With Transposition of the Great Arteries

NCT ID: NCT01120106

Last Updated: 2012-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-09-30

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.

Conditions

Low Cardiac Output Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

levosimendan

levosimendan continuous infusion at a rate of 0.1 mcg/kg\<min

Group Type: ACTIVE_COMPARATOR

levosimendan

Intervention Type: DRUG

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

placebo

Intervention Type: DRUG

saline continuous infusion

placebo

saline infusion

Group Type: PLACEBO_COMPARATOR

levosimendan

Intervention Type: DRUG

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

placebo

Intervention Type: DRUG

saline continuous infusion

Interventions

levosimendan

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

Intervention Type: DRUG

placebo

saline continuous infusion

Intervention Type: DRUG

Other Intervention Names

simdax; saline

Eligibility Criteria

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)

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 30 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bambino Gesù Hospital and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Zaccaria Ricci

medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sergio Picardo, MD, Head

Role: STUDY_DIRECTOR

Bambino Gesù Hospital

Locations

Bambino Gesù Hospital

Rome, , Italy

Countries

Italy

References

Di Chiara L, Ricci Z, Garisto C, Morelli S, Giorni C, Vitale V, Di Donato RM, Picardo S. Initial experience with levosimendan infusion for preoperative management of hypoplastic left heart syndrome. Pediatr Cardiol. 2010 Jan;31(1):166-7. doi: 10.1007/s00246-009-9571-6. No abstract available.

Reference Type: BACKGROUND

PMID: 19915896 (View on PubMed)

Osthaus WA, Boethig D, Winterhalter M, Huber D, Goerler H, Sasse M, Sumpelmann R. First experiences with intraoperative Levosimendan in pediatric cardiac surgery. Eur J Pediatr. 2009 Jun;168(6):735-40. doi: 10.1007/s00431-008-0834-7. Epub 2008 Sep 24.

Reference Type: BACKGROUND

PMID: 18813947 (View on PubMed)

Other Identifiers

levoTGA1

Identifier Type: -

Identifier Source: org_study_id