Trails Center.org

Clinical Trial Name - Levosimendan in Congenital Cardiac Surgery

 
Original Study ID : Levosimendan
NCT ID : NCT00695929
Brief Title : Levosimendan in Congenital Cardiac Surgery
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.

Source : Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Overall Status : Recruiting
Start Date : July 2008
End Date : October 2009
Completion Date : October 2009
Official Title : N/A
Phase : Interventional
Study Design : Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study
Enrollment : 50
Verification Date : November 2008
First Received Date : June 10, 2008
Trial Eligibility
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
Gender : Both
Minimum Age : N/A
Maximum Age : 5 Years
Healthy Volunteers : No
Facilities
Facility Name : Cliniques Universitaires Saint Luc
Status : Recruiting
City : Brussels
Zip Code : 1200
Country : Belgium
Refferances
PMID : 17377079
Citation : 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 text.
PMID : 16885788
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.
OutComes
Primary OutComes
Measure : serum lactate
Time Frame : 12 h postoperatively
Safety issue : Yes
Interventions
Type : Drug
Name : Levosimendan
Description : Intravenous injection
Type : Drug
Name : Milrinone
Description : Intravenous injection
 
Search Trials By
Search
 
Research
 
 
Most Popular Trials
 
Library
 
Discuss