Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

May 6, 2010
June 22, 2012
January 2009
December 2010   (final data collection date for primary outcome measure)
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.
reduction in inotropes and vasopressors requirements (calculated as inotropic score) in treated patients [ Time Frame: from intensive care unit admission after surgery to 72 post operative hours ] [ 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.
Complete list of historical versions of study NCT01120106 on ClinicalTrials.gov Archive Site
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
Low cardiac output syndrome (LCOS) incidence reduction in the treatment group [ Time Frame: from intensive care unit admission after surgery to 72 post operative hours ] [ 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
Not Provided
Not Provided
 
Levosimendan Administration in Neonates With Transposition of the Great Arteries
Perioperative Levosimendan Administration in Neonates With Transposition of the Great Arteries: Randomized Controlled Trial

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Low Cardiac Output Syndrome
  • 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
  • Active Comparator: levosimendan
    levosimendan continuous infusion at a rate of 0.1 mcg/kg<min
    Interventions:
    • Drug: levosimendan
    • Drug: placebo
  • Placebo Comparator: placebo
    saline infusion
    Interventions:
    • Drug: levosimendan
    • Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
September 2011
December 2010   (final data collection date for primary outcome measure)

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)
Both
up to 30 Days
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01120106
levoTGA1
No
Zaccaria Ricci, Bambino Gesù Hospital and Research Institute
Bambino Gesù Hospital and Research Institute
Not Provided
Study Director: Sergio Picardo, MD, Head Bambino Gesù Hospital
Bambino Gesù Hospital and Research Institute
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP