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| Name | Class |
|---|---|
| Silpakorn University | OTHER |
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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.
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who were admitted to Phramongkutklao Hospital as inpatients.
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| Name | Affiliation | Role |
|---|---|---|
| Pasiri Sithinamsuwan, MD | Pharmongkutklao Hospital and College of Medicine | Study Chair |
| Daraporn Rungprai, BCP | Faculty of Pharmacy, Silpakorn University | Study Director |
| Juthathip Suphanklang, BCP | Faculty of Pharmacy, Silpakorn University | Study Director |
| Wongsakorn Promken, B Pharm | The College of Pharmacotherapy of Thailand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmongkutklao Hospital | Ratchathewi | Bangkok | 10400 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10722121 | Background | Patsalos PN. Pharmacokinetic profile of levetiracetam: toward ideal characteristics. Pharmacol Ther. 2000 Feb;85(2):77-85. doi: 10.1016/s0163-7258(99)00052-2. | |
| 15301575 | Background | Patsalos PN. Clinical pharmacokinetics of levetiracetam. Clin Pharmacokinet. 2004;43(11):707-24. doi: 10.2165/00003088-200443110-00002. |
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| ID | Term |
|---|---|
| D012640 | Seizures |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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plasma
Measured Levetiracetam plasma concentration (mcg/mL) of the subjects on dialysis day
| 1 hour after finishing an administration of Levetiracetam post-hemodialysis supplemental dose |
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 |
| 27546759 | Background | Smetana KS, Cook AM, Bastin ML, Oyler DR. Antiepileptic dosing for critically ill adult patients receiving renal replacement therapy. J Crit Care. 2016 Dec;36:116-124. doi: 10.1016/j.jcrc.2016.06.023. Epub 2016 Jul 5. |
| 28294369 | Background | Engelbrecht L, Grobler CJ, Rheeders M. A simple and cost-effective HPLC-UV method for the detection of levetiracetam in plasma/serum of patients with epilepsy. Biomed Chromatogr. 2017 Oct;31(10). doi: 10.1002/bmc.3969. Epub 2017 Apr 20. |
| 30096051 | Background | Jarvie D, Mahmoud SH. Therapeutic Drug Monitoring of Levetiracetam in Select Populations. J Pharm Pharm Sci. 2018;21(1s):149s-176s. doi: 10.18433/jpps30081. |
| 25312351 | Background | Yamamoto J, Toublanc N, Kumagai Y, Stockis A. Levetiracetam pharmacokinetics in Japanese subjects with renal impairment. Clin Drug Investig. 2014 Nov;34(11):819-28. doi: 10.1007/s40261-014-0237-7. |
| 28582998 | Background | Shiue HJ, Taylor M, Sands KA. Comparison of Levetiracetam Dosing Regimens in End-Stage Renal Disease Patients Undergoing Intermittent Hemodialysis. Ann Pharmacother. 2017 Oct;51(10):862-865. doi: 10.1177/1060028017713294. Epub 2017 Jun 5. |
| 28828726 | Background | Wieruszewski PM, Kashani KB, Rabinstein AA, Frazee E. Levetiracetam Pharmacokinetics in a Critically Ill Anephric Patient on Intermittent Hemodialysis. Neurocrit Care. 2018 Apr;28(2):243-246. doi: 10.1007/s12028-017-0441-4. |
| 28555936 | Background | Company-Albir MJ, Ruiz-Ramos J, Solana Altabella A, Marques-Minana MR, Vicent C, Poveda JL. Haemodialysis significantly reduces serum levetiracetam levels inducing epileptic seizures: Case report. J Clin Pharm Ther. 2017 Dec;42(6):774-775. doi: 10.1111/jcpt.12568. Epub 2017 May 28. |