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Levosimendan in Congenital Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT00695929
Recruitment Status : Completed
First Posted : June 12, 2008
Last Update Posted : January 26, 2010
Sponsor:
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

June 10, 2008
June 12, 2008
January 26, 2010
July 2008
September 2009   (Final data collection date for primary outcome measure)
serum lactate [ Time Frame: 12 h postoperatively ]
Same as current
Complete list of historical versions of study NCT00695929 on ClinicalTrials.gov Archive Site
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Levosimendan in Congenital Cardiac Surgery
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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.
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Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Congenital Cardiovascular Defects
  • Low Cardiac Output Syndrome
  • Drug: Levosimendan
    Intravenous injection
  • Drug: Milrinone
    Intravenous injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
Same as current
October 2009
September 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 5 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00695929
Levosimendan
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MONA MOMENI, Cliniques Universitaires saint Luc
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Not Provided
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Cliniques universitaires Saint-Luc- Université Catholique de Louvain
January 2010

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