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 range

0 Days – 18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Acute Heart Failure trials

Who can participate

Age range

0 Days – 18 Years

Sex

ALL

See this in plain English?

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

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.