Pharmacokinetics of Levosimendan in Children with Acute Heart Failure
Completed
- Conditions
- Heartfailure10019280
- Registration Number
- NL-OMON37072
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
Inclusion Criteria
Children < 16 years of age with heartfailure admiited to the pediatric intensive care and who will recieve levosimendan as part of their treatment.
Informed consent from parents
Exclusion Criteria
No informed consent.
Contraindications for levosimendan (arrhytmias, hypotension)
No sampling line
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to describe the pharmacokinetic profile of<br /><br>Levosimendan in children of different age groups (<6 months and > 6 months).<br /><br>With the knowledge of the pharmacokinetic profile of this useful drug we can<br /><br>come to a more rational and evidence based pharmacotherapy in children. When<br /><br>the pharmacokinetic profile is known, we can further assess the effectiveness<br /><br>of Levosimendan in future trials.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objective is to describe the pharmacodynamic profile of<br /><br>levosimendan by assessing the clinical effect of levosimendan therapy on heart<br /><br>rate, blood pressure, lactate, troponin, pro-BNP, venous saturation and cardiac<br /><br>function with echocardiography.<br /><br><br /><br>Acetylator status<br /><br><br /><br>Expected side effects: hypotension, arrhythmias<br /><br>Serious Adverse Events (SAE)<br /><br>Suspected Unexpected Serious Adverse Reactions (SUSARs) </p><br>