The Study of Pharmacokinetics of Levetiracetam in Patients Undergoing Intermittent Hemodialysis

NCT04511676 | Completed

• 1 other identifier: LEV-HD
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Seizures

Keywords

Levetiracetam; Pharmacokinetics; Hemodialysis

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (3)

• Plasma concentration of Levetiracetam

  Immediately before Levetiracetam administration

• Plasma concentration of Levetiracetam

  1 hour after finishing Levetiracetam administration

• Number of participants with adverse drug reactions from 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were admitted to Phramongkutklao Hospital as inpatients.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Phramongkutklao College of Medicine and Hospital: lead
• Silpakorn University: collaborator

Study Sites (1)

Pharmongkutklao Hospital

Ratchathewi, Bangkok, 10400, Thailand

Location

Related Publications (9)

• 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.

  PMID: 10722121 BACKGROUND

• Patsalos PN. Clinical pharmacokinetics of levetiracetam. Clin Pharmacokinet. 2004;43(11):707-24. doi: 10.2165/00003088-200443110-00002.

  PMID: 15301575 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.

  PMID: 27546759 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.

  PMID: 28294369 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.

  PMID: 30096051 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.

  PMID: 25312351 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.

  PMID: 28582998 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.

  PMID: 28828726 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.

  PMID: 28555936 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Seizures

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 13, 2020
• Study Start: November 1, 2018
• Primary Completion: October 10, 2019
• Study Completion: October 10, 2019
• Last Updated: August 13, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)