Pharmacokinetics of Levosimendan in Pediatric Intensive Care Units

Nantes University Hospital27 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Acute Heart Failure

Eligibility

Sex: ALLMin age: 0 DaysMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU de Nantes

Nantes, France

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: At the end of the study, after 2 years.

Data from ClinicalTrials.gov

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