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Trials / Completed

CompletedNCT03681379

Pharmacokinetics of Levosimendan in Pediatric Intensive Care Units

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

Status
Completed
Phase
Study type
Observational
Enrollment
27 (actual)
Sponsor
Nantes University Hospital · Academic / Other
Sex
All
Age
0 Days – 18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2018-09-23
Primary completion
2019-10-11
Completion
2020-10-01
First posted
2018-09-24
Last updated
2024-08-02

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03681379. Inclusion in this directory is not an endorsement.

Pharmacokinetics of Levosimendan in Pediatric Intensive Care Units (NCT03681379) · Clinical Trials Directory