Levosimendan Administration in Neonates With Transposition of the Great Arteries
Primary Purpose
Low Cardiac Output Syndrome
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
levosimendan
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Low Cardiac Output Syndrome focused on measuring levosimendan, pediatric cardiac surgery, low cardiac output syndrome, transposition of the great arteries
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)
Sites / Locations
- Bambino Gesù Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
levosimendan
placebo
Arm Description
levosimendan continuous infusion at a rate of 0.1 mcg/kg<min
saline infusion
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Low cardiac output syndrome (LCOS) incidence reduction in the treatment group
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
Full Information
NCT ID
NCT01120106
First Posted
May 6, 2010
Last Updated
June 22, 2012
Sponsor
Bambino Gesù Hospital and Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01120106
Brief Title
Levosimendan Administration in Neonates With Transposition of the Great Arteries
Official Title
Perioperative Levosimendan Administration in Neonates With Transposition of the Great Arteries: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bambino Gesù Hospital and Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Cardiac Output Syndrome
Keywords
levosimendan, pediatric cardiac surgery, low cardiac output syndrome, transposition of the great arteries
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
levosimendan
Arm Type
Active Comparator
Arm Description
levosimendan continuous infusion at a rate of 0.1 mcg/kg<min
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
saline infusion
Intervention Type
Drug
Intervention Name(s)
levosimendan
Other Intervention Name(s)
simdax
Intervention Description
patients enrolled in this group will receive a levosimendan continuous infusion at a rate of 0.1 mcg/kg/min
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
saline
Intervention Description
saline continuous infusion
Primary Outcome Measure Information:
Title
lower inotropic score in the levosimendan group
Description
inotropic score will be calculated as: dopamine (mcg/Kg/min) * 1 + milrinone (mcg/Kg/min) * 15 + epinephrine (mcg/Kg/min) * 100.
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)
Secondary Outcome Measure Information:
Title
Low cardiac output syndrome (LCOS) incidence reduction in the treatment group
Description
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
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio Picardo, MD, Head
Organizational Affiliation
Bambino Gesù Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Bambino Gesù Hospital
City
Rome
ZIP/Postal Code
00165
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
19915896
Citation
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.
Results Reference
background
PubMed Identifier
18813947
Citation
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.
Results Reference
background
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Levosimendan Administration in Neonates With Transposition of the Great Arteries
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