Pharmacokinetics of Levosimendan in Pediatric Intensive Care Units

Completed

• Conditions: Acute Heart Failure

• Registration Number: NCT03681379
• Lead Sponsor: Nantes University Hospital

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.

Study Timeline

• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-09-21
• Study Start: 2018-09-23
• Study First Posted: 2018-09-24
• Primary Completion: 2019-10-11
• Study Completion: 2020-10-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

CHU de Nantes; 🇫🇷 Nantes, France