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Levosimendan in Congenital Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00695929
First received: June 10, 2008
Last updated: January 25, 2010
Last verified: January 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • serum lactate [ Time Frame: 12 h postoperatively ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 10, 2008
Last Updated: January 25, 2010
Health Authority: Belgium: Institutional Review Board

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
Milrinone
Simendan
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
 Vasodilator Agents
Cardiovascular Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on May 22, 2013