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To describe pharmacokinetics of levosimendan in neonates and children supported or not with extracorporeal circulation devices (ECMO, CRRT)
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.
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| Measure | Description | Time Frame |
|---|---|---|
| First parameter of the pharmacokinetics of levosimendan, OR1855, OR1896 (Area under the plasma concentration versus time curve (AUC) ) | 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 | At the end of the study, after 2 years. |
| second parameter of the pharmacokinetics of levosimendan, OR1855, OR1896 (distribution volume) | distribution volume of levosimendan, OR 1855 and OR 1896. Samples will be collected over a period in of 192h in context of routine care | At the end of the study, after 2 years. |
| third parameter of the pharmacokinetics of levosimendan, OR1855, OR1896 (half-life time) | 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 | At the end of the study, after 2 years. |
| fourth parameter of the pharmacokinetics of levosimendan, OR1855, OR1896 (Peak Plasma Concentration (Cmax)) | 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 | At the end of the study, after 2 years. |
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Inclusion Criteria:
Exclusion Criteria:
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children admitted in pediatric intensive care units for acute heart failure
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Nantes | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12395979 | Background | Kivikko M, Antila S, Eha J, Lehtonen L, Pentikainen PJ. Pharmacokinetics of levosimendan and its metabolites during and after a 24-hour continuous infusion in patients with severe heart failure. Int J Clin Pharmacol Ther. 2002 Oct;40(10):465-71. doi: 10.5414/cpp40465. | |
| 36631687 | Derived | Bourgoin P, Lecomte J, Oualha M, Berthomieu L, Pereira T, Davril E, Lamoureux F, Joram N, Chenouard A, Duflot T. Population Pharmacokinetics of Levosimendan and its Metabolites in Critically Ill Neonates and Children Supported or Not by Extracorporeal Membrane Oxygenation. Clin Pharmacokinet. 2023 Feb;62(2):335-348. doi: 10.1007/s40262-022-01199-y. Epub 2023 Jan 11. |
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Patients with acute circulatory insufficiency are equipped with a central venous line or catheterization for hemodynamic monitoring and biological assessment in context of routine care. There will be no specific interventions to the study participants like additional venipuncture for this study. The volume required for the analyzes (0.5 ml, 13 times over a period of 8 days) are issue from hemodynamic monitoring and biological assessment in context of routine care . This volume is compatible with the current french regulation on non interventional research.