Acute heart failure in children
Conditions
Interventions
Product Name: Levosimendan
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: LEVOSIMENDAN
CAS Number: 141505-33-1
Concentration unit: mg/kg/h milligram(s)/kil
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Any child on our PICU who will receive Levosimendan as part of their treatment Are the trial subjects under 18? yes Number of subjects for this age range: 36 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: No Informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the pharmacokinetic profile of levosimendan in children;Secondary Objective: To describe the pharmacodynamic profile of levosimendan by assessing the clinical effect of levosimendan therapy on heart rate, blood pressure, lactate, troponin, pro-BNP, venous saturation and cardiac function with echocardiography. To describe the pharmacokinetic and pharmacodynamic profile of Levosimendan in a specific group of children with severe heart failure requiring support with ECMO. We need to determine if the pharmacokinetic profile is different during ECMO support compared to children who don’t need ECMO support. We aim to include 6 ECMO patients. To describe the pharmacokinetic and pharmacodynamic profile of Levosimendan in a specific group of children who receive Levosimendan before an operation involving cardiopulmonary bypass (CPB). We need to determine if the pharmacokinetic profile is influenced by CPB. We aim to include 6 CPB patients. To assess whether acetylation status affects the pharmacokinetic profile of Levosimendan in children. ;Primary end point(s): Serum levels of levosimendan and its metabolites;Timepoint(s) of evaluation of this end point: After Levosimendaninfusion, levels will be taken daily for 12 days to assess the elimination of levosimendan. The entire study will take 2 years to complete. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): No;Timepoint(s) of evaluation of this end point: No | — |
Countries
Netherlands
Contacts
Public ContactPediatric Intensive Care Unit
Leiden University Medical Center
Outcome results
None listed