Pharmacokinetics of Levosimendan in Pediatric Intensive Care Units

Acute Heart Failure Clinical Trial

— PALMAréa  

Official title:

Pharmacokinetics of Levosimendan, OR1855 and OR1896 in Neonates and Children With or Without Extracorporeal Membrane Oxygenation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03681379
• Other study ID #: RC16_0114
• Status: Not yet recruiting
• Start date: October 1, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: September 2018
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To describe pharmacokinetics of levosimendan in neonates and children supported or not with extracorporeal circulation devices (ECMO, CRRT)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

Kivikko M, Antila S, Eha J, Lehtonen L, Pentikäinen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.