## Protocol Section
### Identification Module
**NCT ID:** NCT03681379

**Acronym:** PALMAréa

**Brief Title:** Pharmacokinetics of Levosimendan in Pediatric Intensive Care Units

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

#### Organization Study ID Info
**ID:** RC16_0114
#### Organization
**Class:** OTHER
**Full Name:** Nantes University Hospital
### Status Module
#### Completion Date
**Date:** 2020-10-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2018-09-24

**Type:** ACTUAL

**Last Update Submit Date:** 2018-09-21

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2020-10-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2018-10-01

**Type:** ESTIMATED

**Status Verified Date:** 2018-09

#### Study First Post Date
**Date:** 2018-09-24
**Type:** ACTUAL
**Study First Submit Date:** 2018-09-18
**Study First Submit QC Date:** 2018-09-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Nantes University Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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 Module

**Conditions:**

- Acute Heart Failure

**Keywords:**

- Levosimendan

- pharmacokinetics

- children

- acute heart failure

### Design Module

#### Bio Spec

**Description:** 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.

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** 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.

**Description:** distribution volume of levosimendan, OR 1855 and OR 1896. Samples will be collected over a period in of 192h in context of routine care

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

**Time Frame:** At the end of the study, after 2 years.

**Description:** 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

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

**Time Frame:** At the end of the study, after 2 years.

**Description:** 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

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

**Time Frame:** At the end of the study, after 2 years.

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

**Study Population:** children admitted in pediatric intensive care units for acute heart failure

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Nantes

**Country:** France

**Facility:** CHU de Nantes

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006333

- Term: Heart Failure

### Intervention Browse Module - Browse Branches

- Abbrev: CaAg

- Name: Cardiotonic Agents

- Abbrev: VaDiAg

- Name: Vasodilator Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M1805

- Name: Simendan

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
