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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
Information provided by:

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.

Condition or disease Intervention/treatment
Congenital Cardiovascular Defects Low Cardiac Output Syndrome Drug: Levosimendan Drug: Milrinone

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : July 2008
Primary Completion Date : September 2009
Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
Drug Information available for: Milrinone
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: Levosimendan
    Intravenous injection
    Drug: Milrinone
    Intravenous injection

Outcome Measures

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

Eligibility Criteria

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

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

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

Responsible Party: MONA MOMENI, Cliniques Universitaires saint Luc
ClinicalTrials.gov Identifier: NCT00695929     History of Changes
Other Study ID Numbers: Levosimendan
First Posted: June 12, 2008    Key Record Dates
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
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