| 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 |
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