Pharmacokinetics of Levosimendan in Children with Acute Heart Failure

Pharmacokinetics of Levosimendan in Children with Acute Heart Failure - LevoCorKids

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37072

Enrollment

Registered

2012-10-11

Start date

2012-12-09

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heartfailure

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Children

Exclusion criteria

Exclusion criteria: No informed consent. Contraindications for levosimendan (arrhytmias, hypotension) No sampling line

Design outcomes

Primary

Measure	Time frame
The primary objective is to describe the pharmacokinetic profile of Levosimendan in children of different age groups ( 6 months). With the knowledge of the pharmacokinetic profile of this useful drug we can come to a more rational and evidence based pharmacotherapy in children. When the pharmacokinetic profile is known, we can further assess the effectiveness of Levosimendan in future trials.	—

Secondary

Measure	Time frame
The secondary objective is to describe the pharmacodynamic profile of levosimendan by assessing the clinical effect of levosimendan therapy on heart rate, blood pressure, lactate, troponin, pro-BNP, venous saturation and cardiac function with echocardiography. Acetylator status Expected side effects: hypotension, arrhythmias Serious Adverse Events (SAE) Suspected Unexpected Serious Adverse Reactions (SUSARs)	—

Measure

Time frame

The secondary objective is to describe the pharmacodynamic profile of levosimendan by assessing the clinical effect of levosimendan therapy on heart rate, blood pressure, lactate, troponin, pro-BNP, venous saturation and cardiac function with echocardiography. Acetylator status Expected side effects: hypotension, arrhythmias Serious Adverse Events (SAE) Suspected Unexpected Serious Adverse Reactions (SUSARs)

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Countries

Netherlands

Outcome results