Levosimendan in Congenital Cardiac Surgery

Low Cardiac Output Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00695929
• Other study ID #: Levosimendan
• Status: Completed
• Phase: N/A
• First received: June 10, 2008
• Last updated: January 25, 2010
• Start date: July 2008
• Est. completion date: October 2009

Study information

• Verified date: January 2010
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Output, Low
• Congenital Cardiovascular Defects
• Low Cardiac Output Syndrome

Intervention

Drug:
• Levosimendan
Intravenous injection
• Milrinone
Intravenous injection

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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. Erratum in: Anesth Analg. 2007 Jun;104(6):1544. Dosage error in article text. — View 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. Erratum in: Pediatr Crit Care Med. 2007 Mar;8(2):197. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum lactate		12 h postoperatively	Yes