Acute Heart Failure
Conditions
Keywords
Levosimendan, pharmacokinetics, children, acute heart failure
Brief summary
To describe pharmacokinetics of levosimendan in neonates and children supported or not with extracorporeal circulation devices (ECMO, CRRT)
Detailed description
Levosimendan is a calcium sensitiver wih inotropic effects. It's use in the context of acute or chronic heart failure in children has yet to be defined. Due to physical proprieties of levosimendan and metabolites, we hypothesized that concomitant use of extracorporeal devices such as ECMO will cause major pharmacokinetic variations. Furthermore, pharmacokinetics of levosimendan in children with multiple organ failure has to be specify.
Interventions
None listed
Sponsors
Nantes University Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Days to 18 Years
Healthy volunteers
No
Inclusion criteria
* All children admitted in pediatric intensive care units with planned infusion of 0.2 mcg/kg/min of levosimendan over 24h in context of routine care * Arterial line or central venous catheter inserted for blood sampling procedures in context of routine care.
Exclusion criteria
* Absence of clear parental status or information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First parameter of the pharmacokinetics of levosimendan, OR1855, OR1896 (Area under the plasma concentration versus time curve (AUC) ) | At the end of the study, after 2 years. | Area under the plasma concentration versus time curve (AUC) of levosimendan, OR 1855 and OR 1896. Samples will be collected over a period in of 192h in context of routine care |
| second parameter of the pharmacokinetics of levosimendan, OR1855, OR1896 (distribution volume) | At the end of the study, after 2 years. | distribution volume of levosimendan, OR 1855 and OR 1896. Samples will be collected over a period in of 192h in context of routine care |
| third parameter of the pharmacokinetics of levosimendan, OR1855, OR1896 (half-life time) | At the end of the study, after 2 years. | half-life time of levosimendan, OR 1855 and OR 1896. Samples will be collected over a period in of 192h in context of routine care |
| fourth parameter of the pharmacokinetics of levosimendan, OR1855, OR1896 (Peak Plasma Concentration (Cmax)) | At the end of the study, after 2 years. | Peak Plasma Concentration (Cmax) of levosimendan, OR 1855 and OR 1896. Samples will be collected over a period in of 192h in context of routine care |
Countries
France
Outcome results
None listed