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Levosimendan in Congenital Cardiac Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00695929
First Posted: June 12, 2008
Last Update Posted: January 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  Purpose
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.

Condition Intervention
Congenital Cardiovascular Defects Low Cardiac Output Syndrome Drug: Levosimendan Drug: Milrinone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • serum lactate [ Time Frame: 12 h postoperatively ]

Estimated Enrollment: 50
Study Start Date: July 2008
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Levosimendan
    Intravenous injection
    Drug: Milrinone
    Intravenous injection
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00695929


Locations
Belgium
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  More Information

Publications:
Responsible Party: MONA MOMENI, Cliniques Universitaires saint Luc
ClinicalTrials.gov Identifier: NCT00695929     History of Changes
Other Study ID Numbers: Levosimendan
First Submitted: June 10, 2008
First Posted: June 12, 2008
Last Update Posted: January 26, 2010
Last Verified: January 2010

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
cardiac surgery with cardiopulmonary bypass

Additional relevant MeSH terms:
Cardiac Output, Low
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms
Simendan
Milrinone
Anti-Arrhythmia Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Phosphodiesterase 3 Inhibitors