Clinical trial NCT04511676: The Study of Pharmacokinetics of Levetiracetam in Patients Undergoing Intermittent Hemodialysis
Official title: The Study of Pharmacokinetics of Levetiracetam in Patients Undergoing Intermittent Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Seizures
Keywords: Levetiracetam
Pharmacokinetics
Hemodialysis
Lead sponsor: Phramongkutklao College of Medicine and Hospital
Sponsor class: OTHER
Collaborators: name: Silpakorn University
First posted: 2020-08-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were admitted to Phramongkutklao Hospital as inpatients.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Patients who were at least 18 years old.
2. Patients who were diagnosed with seizure.
3. Patients who were undergoing intermittent hemodialysis and were treated with intravenous Levetiracetam not less than 2 days

Exclusion Criteria:

1. Patients who were pregnant or lactating
2. Patients who were treated with intravenous Levetiracetam more than once a day
3. Patients who were undergoing sustained low efficiency dialysis (SLED)
4. Patients who have intermittent dialysis duration less than 3 hours

Primary outcomes:
measure: Plasma concentration of Levetiracetam
timeFrame: Immediately before an initiation of an intermittent hemodialysis session
measure: Plasma concentration of Levetiracetam
timeFrame: 1 hour after an initiation of an intermittent hemodialysis session
measure: Plasma concentration of Levetiracetam
timeFrame: 2 hour after an initiation of an intermittent hemodialysis session
measure: Plasma concentration of Levetiracetam
timeFrame: 3 hour after an initiation of an intermittent hemodialysis session
measure: Plasma concentration of Levetiracetam
timeFrame: 4 hour after an initiation of an intermittent hemodialysis session
measure: Plasma concentration of Levetiracetam
timeFrame: Before an administration of Levetiracetam post-hemodialysis supplemental dose
measure: Plasma concentration of Levetiracetam
timeFrame: 1 hour after finishing an administration of Levetiracetam post-hemodialysis supplemental dose
Secondary outcomes:
measure: Plasma concentration of Levetiracetam
timeFrame: Immediately before Levetiracetam administration
measure: Plasma concentration of Levetiracetam
timeFrame: 1 hour after finishing Levetiracetam administration
measure: Number of participants with adverse drug reactions from Levetiracetam
timeFrame: 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
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Pharmongkutklao Hospital
state: Bangkok
Study officials:
affiliation: Pharmongkutklao Hospital and College of Medicine
name: Pasiri Sithinamsuwan, MD
role: STUDY_CHAIR
affiliation: Faculty of Pharmacy, Silpakorn University
name: Daraporn Rungprai, BCP
role: STUDY_DIRECTOR
affiliation: Faculty of Pharmacy, Silpakorn University
name: Juthathip Suphanklang, BCP
role: STUDY_DIRECTOR
affiliation: The College of Pharmacotherapy of Thailand
name: Wongsakorn Promken, B Pharm
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.