CompletedNot Applicable

Pharmacokinetics of Levosimendan in Pediatric Intensive Care Units

France27 participantsStarted 2018-09-23

Plain-language summary

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

Who can participate

Age range0 Days – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: At the end of the study, after 2 years.

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

Timeframe: At the end of the study, after 2 years.

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

Timeframe: At the end of the study, after 2 years.

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

Timeframe: At the end of the study, after 2 years.

Trial details

NCT IDNCT03681379

SponsorNantes University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-10-11

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