The Study of Pharmacokinetics of Levetiracetam in Patients Undergoing Intermittent Hemodialysis

Study Overview
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Brief Summary
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Levetiracetam (LEV) is one of second-generation antiepileptic drugs that has been used to treat partial and generalized epilepsy. LEV is eliminated from the systemic circulation by renal excretion. Therefore, patients with renal impairment may experience a reduced drug excretion and increased adverse drug reactions. Moreover, patients with end-stage renal disease who need dialysis may experience low serum LEV concentration because of drug loss via dialysis. LEV loss via dialysis can cause low serum level of LEV that insufficient for seizure control. The present study was aimed to evaluate pharmacokinetics of LEV in patients undergoing 4 hour-intermittent hemodialysis (IHD). The results of the study may benefit to determine the appropriate LEV initial dose and supplemental dose for patients undergoing IHD.

Official Title
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The Study of Pharmacokinetics of Levetiracetam in Patients Undergoing Intermittent Hemodialysis

Conditions
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Seizures

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who were at least 18 years old. Patients who were diagnosed with seizure. Patients who were undergoing intermittent hemodialysis and were treated with intravenous Levetiracetam not less than 2 days Exclusion Criteria: Patients who were pregnant or lactating Patients who were treated with intravenous Levetiracetam more than once a day Patients who were undergoing sustained low efficiency dialysis (SLED) Patients who have intermittent dialysis duration less than 3 hours

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of Levetiracetam | Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day | Immediately before an initiation of an intermittent hemodialysis session | 
| Plasma concentration of Levetiracetam | Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day | 1 hour after an initiation of an intermittent hemodialysis session | 
| Plasma concentration of Levetiracetam | Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day | 2 hour after an initiation of an intermittent hemodialysis session | 
| Plasma concentration of Levetiracetam | Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day | 3 hour after an initiation of an intermittent hemodialysis session | 
| Plasma concentration of Levetiracetam | Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day | 4 hour after an initiation of an intermittent hemodialysis session | 
| Plasma concentration of Levetiracetam | Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day | Before an administration of Levetiracetam post-hemodialysis supplemental dose | 
| Plasma concentration of Levetiracetam | Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day | 1 hour after finishing an administration of Levetiracetam post-hemodialysis supplemental dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of Levetiracetam | Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on non-dialysis day. | Immediately before Levetiracetam administration | 
| Plasma concentration of Levetiracetam | Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on non-dialysis day. | 1 hour after finishing Levetiracetam administration | 
| Number of participants with adverse drug reactions from Levetiracetam | Observed signs and symptoms of Levetiracetam adverse drug reactions after participants were administered with Levetiracetam. | From the first day that participants were included to the study and treated with Levetiracetam until the date of the last point of serum Levetiracetam sampling, assessed up to 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Levetiracetam, Pharmacokinetics, Hemodialysis