NCT00695929CompletedNot Applicable
Levosimendan in Congenital Cardiac Surgery
Cliniques universitaires Saint-Luc- Université Catholique de Louvain2 sites in 1 country50 target enrollmentStarted: July 1, 2008Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- serum lactate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 1 Day to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
serum lactate
Time Frame: 12 h postoperatively
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Phase 4
Levosimendan Versus Combination With Magnesium Sulphate on Spine Protection by NIRS in Infants Undergoing CoarctectomyAortic CoarctationNCT04330755Dalia Saad Abd-El Kader40
Unknown
Not Applicable
Levosimendan Pharmacokinetics in ChildrenAcute Heart FailureNCT01704131Leiden University Medical Center36
Unknown
Phase 2
Levosimendan in Patients With Impaired Right Ventricular Function Undergoing Cardiac SurgeryOpen-heart SurgeryRight Heart FailureNCT05063370Ain Shams University40
Completed
Phase 2
Levosimendan Administration in Neonates With Transposition of the Great ArteriesLow Cardiac Output SyndromeNCT01120106Bambino Gesù Hospital and Research Institute63
Withdrawn
Phase 4
Preoperative Levosimendan and Heart FailureHeart FailureHip FractureNCT01022983Sykehuset i Vestfold HF