Pharmacokinetics of Levosimendan in Pediatric Intensive Care Units

NCT03681379 | Completed

• 1 other identifier: RC16_0114
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Heart Failure

Keywords

Levosimendan; pharmacokinetics; children; acute heart failure

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Eligibility Criteria

• Age: 0 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

children admitted in pediatric intensive care units for acute heart failure

You may qualify if:

• 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.

You may not qualify if:

• Absence of clear parental status or information

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, France

Location

Related Publications (2)

• Kivikko M, Antila S, Eha J, Lehtonen L, Pentikainen 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. doi: 10.5414/cpp40465.

  PMID: 12395979 BACKGROUND

• Bourgoin P, Lecomte J, Oualha M, Berthomieu L, Pereira T, Davril E, Lamoureux F, Joram N, Chenouard A, Duflot T. Population Pharmacokinetics of Levosimendan and its Metabolites in Critically Ill Neonates and Children Supported or Not by Extracorporeal Membrane Oxygenation. Clin Pharmacokinet. 2023 Feb;62(2):335-348. doi: 10.1007/s40262-022-01199-y. Epub 2023 Jan 11.

  PMID: 36631687 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Patients with acute circulatory insufficiency are equipped with a central venous line or catheterization for hemodynamic monitoring and biological assessment in context of routine care. There will be no specific interventions to the study participants like additional venipuncture for this study. The volume required for the analyzes (0.5 ml, 13 times over a period of 8 days) are issue from hemodynamic monitoring and biological assessment in context of routine care . This volume is compatible with the current french regulation on non interventional research.

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 24, 2018
• Study Start: September 23, 2018
• Primary Completion: October 11, 2019
• Study Completion: October 1, 2020
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)