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Completed

NCT Number: NCT03681379

Pharmacokinetics of Levosimendan in Pediatric Intensive Care Units

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

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Key information

Conditions

Acute Heart Failure

Age range

0 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nantes

Nantes, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. First parameter of the pharmacokinetics of levosimendan, OR1855, OR1896 (Area under the plasma concentration versus time curve (AUC) )

    Time frame: 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

  2. second parameter of the pharmacokinetics of levosimendan, OR1855, OR1896 (distribution volume)

    Time frame: 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

  3. third parameter of the pharmacokinetics of levosimendan, OR1855, OR1896 (half-life time)

    Time frame: 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

  4. fourth parameter of the pharmacokinetics of levosimendan, OR1855, OR1896 (Peak Plasma Concentration (Cmax))

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: PALMAréa

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 24, 2018
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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