Levosimendan Administration in Neonates With Transposition of the Great Arteries

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zaccaria Ricci, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier:
NCT01120106
First received: May 6, 2010
Last updated: June 22, 2012
Last verified: June 2012
  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

Resource links provided by NLM:


Further study details as provided by Bambino Gesù Hospital and Research Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01120106

Locations
Italy
Bambino Gesù Hospital
Rome, Italy, 00165
Sponsors and Collaborators
Bambino Gesù Hospital and Research Institute
Investigators
Study Director: Sergio Picardo, MD, Head Bambino Gesù Hospital
  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 July 29, 2014