Levosimendan Administration in Neonates With Transposition of the Great Arteries

NCT01120106 | Completed Phase 2

• 1 other identifier: levoTGA1
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Cardiac Output Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (2)

levosimendan

ACTIVE COMPARATOR

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

Drug: levosimendan; Drug: placebo

placebo

PLACEBO COMPARATOR

saline infusion

Drug: levosimendan; Drug: placebo

Interventions

levosimendan DRUG

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

Also known as: simdax

levosimendan; placebo

placebo DRUG

saline continuous infusion

Also known as: saline

levosimendan; placebo

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• neonates affected by transposition of the great arteries scheduled to elective surgery

You may not qualify if:

• neonates affected by transposition of the great arteries who are not scheduled to elective surgery (urgent procedures, patients older than 30 days)

Sponsors & Collaborators

• Bambino Gesù Hospital and Research Institute: lead

Study Sites (1)

Bambino Gesù Hospital

Rome, 00165, Italy

Location

Related Publications (2)

• 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.

  PMID: 19915896 BACKGROUND

• 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.

  PMID: 18813947 BACKGROUND

MeSH Terms

Conditions

Cardiac Output, Low; Transposition of Great Vessels

Interventions

Simendan; Sodium Chloride

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Sergio Picardo, MD, Head

  Bambino Gesù Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 10, 2010
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: September 1, 2011
• Last Updated: June 26, 2012

Record last verified: 2012-06

Locations

IT (1)