Levosimendan in Congenital Cardiac Surgery
Primary Purpose
Congenital Cardiovascular Defects, Low Cardiac Output Syndrome
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Levosimendan
Milrinone
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Cardiovascular Defects focused on measuring cardiac surgery with cardiopulmonary bypass
Eligibility Criteria
Inclusion Criteria:
- Pediatric patients undergoing complex cardiac surgery under cardiopulmonary bypass and requiring inotropic support
Exclusion Criteria:
- Patients with renal and/or hepatic dysfunction
- Patients requiring inotropic support before their surgery
- Septic patients
Sites / Locations
- Cliniques Universitaires Saint Luc
Outcomes
Primary Outcome Measures
serum lactate
Secondary Outcome Measures
Full Information
NCT ID
NCT00695929
First Posted
June 10, 2008
Last Updated
January 25, 2010
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT00695929
Brief Title
Levosimendan in Congenital Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
5. Study Description
Brief Summary
Many pediatric patients undergoing cardiac surgery under cardiopulmonary bypass for repair of complex congenital malformations, require inotropic support for low cardiac output syndrome. Milrinone through its positive inotropic and vasodilatory effects is widely used for this purpose. The aim of the study is to compare Milrinone with Levosimendan, a novel inotope with calcium-sensitizing properties. We hypothesized that using Levosimendan would result in reduced serum lactate through a higher cardiac index.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Cardiovascular Defects, Low Cardiac Output Syndrome
Keywords
cardiac surgery with cardiopulmonary bypass
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Levosimendan
Intervention Description
Intravenous injection
Intervention Type
Drug
Intervention Name(s)
Milrinone
Intervention Description
Intravenous injection
Primary Outcome Measure Information:
Title
serum lactate
Time Frame
12 h postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pediatric patients undergoing complex cardiac surgery under cardiopulmonary bypass and requiring inotropic support
Exclusion Criteria:
Patients with renal and/or hepatic dysfunction
Patients requiring inotropic support before their surgery
Septic patients
Facility Information:
Facility Name
Cliniques Universitaires Saint Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
17377079
Citation
De Hert SG, Lorsomradee S, Cromheecke S, Van der Linden PJ. The effects of levosimendan in cardiac surgery patients with poor left ventricular function. Anesth Analg. 2007 Apr;104(4):766-73. doi: 10.1213/01.ane.0000256863.92050.d3. Erratum In: Anesth Analg. 2007 Jun;104(6):1544. Dosage error in article text.
Results Reference
background
PubMed Identifier
16885788
Citation
Namachivayam P, Crossland DS, Butt WW, Shekerdemian LS. Early experience with Levosimendan in children with ventricular dysfunction. Pediatr Crit Care Med. 2006 Sep;7(5):445-8. doi: 10.1097/01.PCC.0000235251.14491.75. Erratum In: Pediatr Crit Care Med. 2007 Mar;8(2):197.
Results Reference
background
PubMed Identifier
15329162
Citation
Turanlahti M, Boldt T, Palkama T, Antila S, Lehtonen L, Pesonen E. Pharmacokinetics of levosimendan in pediatric patients evaluated for cardiac surgery. Pediatr Crit Care Med. 2004 Sep;5(5):457-62. doi: 10.1097/01.pcc.0000137355.01277.9c.
Results Reference
result
Learn more about this trial
Levosimendan in Congenital Cardiac Surgery
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