Levosimendan in Congenital Cardiac Surgery
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2008
CompletedFirst Posted
Study publicly available on registry
June 12, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedJanuary 26, 2010
January 1, 2010
1.2 years
June 10, 2008
January 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
serum lactate
12 h postoperatively
Interventions
Intravenous injection
Intravenous injection
Eligibility Criteria
You may qualify if:
- Pediatric patients undergoing complex cardiac surgery under cardiopulmonary bypass and requiring inotropic support
You may not qualify if:
- Patients with renal and/or hepatic dysfunction
- Patients requiring inotropic support before their surgery
- Septic patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
Related 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. doi: 10.1213/01.ane.0000256863.92050.d3.
PMID: 17377079BACKGROUNDNamachivayam 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. doi: 10.1097/01.PCC.0000235251.14491.75.
PMID: 16885788BACKGROUNDTuranlahti 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. doi: 10.1097/01.pcc.0000137355.01277.9c.
PMID: 15329162RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 10, 2008
First Posted
June 12, 2008
Study Start
July 1, 2008
Primary Completion
September 1, 2009
Study Completion
October 1, 2009
Last Updated
January 26, 2010
Record last verified: 2010-01